Medically assisted nutrition for adult palliative care patients
Abstract
Background
Many palliative care patients have a reduced oral intake during their illness. The management of this can include the provision of medically assisted nutrition with the aim of prolonging the length of life of a patient, improving their quality of life, or both. This is an updated version of the original Cochrane review published in Issue 4, 2008.
Objectives
To determine the effect of medically assisted nutrition on the quality and length of life of palliative care patients.
Search methods
We identified studies from searching Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, CANCERLIT, Caresearch, Dissertation abstracts, SCIENCE CITATION INDEX and the reference lists of all eligible trials, key textbooks and previous systematic reviews. The date of the latest search was 26 March 2014.
Selection criteria
All relevant randomised controlled trials (RCTs) or prospective controlled trials (if no RCTs were found).
Data collection and analysis
We found no RCTs or prospectively controlled trials that met the inclusion criteria.
Main results
The original review identified four prospective non‐controlled trials and the updated search in 2014 identified one more (plus an updated version of a Cochrane review on enteral feeding in motor neuron disease). There were five prospective non‐controlled trials (including one qualitative study) that studied medically assisted nutrition in palliative care participants, and one Cochrane systematic review (on motor neuron disease that found no RCTs), but no RCTs or prospective controlled studies.
Authors' conclusions
Since the last version of this review, we found no new studies. There are insufficient good‐quality trials to make any recommendations for practice with regards to the use of medically assisted nutrition in palliative care patients.
Plain language summary
Medically assisted nutrition to assist palliative care patients
Background
It is common for palliative care patients to have reduced oral intake during their illness. Management of this condition includes discussion with the patient, family and staff involved, and may include giving nutrition with medical assistance. This can be done either via a plastic tube inserted directly into a vein or into the stomach or other parts of the gastrointestinal tract. It is unknown whether this treatment helps people to feel better or live longer.
Study characteristics
We searched the international literature for randomised controlled trials looking at the effects of medically assisted nutrition in adults receiving palliative care. Randomised controlled trials allocate patients to one of two or more treatment groups in a random manner and provide the most accurate information on the best treatment. The search was conducted in April 2013 and March 2014.
Key results
We found no randomised controlled trials. As a result, it is not possible to define the benefits and harms of this treatment clearly.
Authors' conclusions
Background
This review is an update of a previously published review in The Cochrane Library (Issue 2, 2008) on "Medically assisted nutrition for palliative care in adult patients" (Good 2008). Many palliative care patients have a reduced oral intake during their illness. The cause of this varies, but may be part of a physical obstruction, anorexia/cachexia syndrome, generalised weakness, bowel obstruction, loss of desire to eat or no specific cause may be identified. The most common time for this decreased oral intake is during the terminal phase, when the patient becomes less conscious and, therefore, less able to receive nutrition orally (Morita 1998).
Management of this condition includes discussion with the patient, family and staff involved and either no medical intervention (but continued attention to treating any symptomatic problems, including good mouth care) or the provision of nutrition with medical assistance. The aim of this intervention can be to prolong the length of life of a participant, improve their quality of life (QoL), or both. These benefits may come via the reversal of the physiological factors associated with the patient's decline. Balanced against these potential benefits are adverse events that can be associated with any intervention (infection, bleeding, pain, etc.) (Bozzetti 1996). It is also essential to assess the psychological and the spiritual impact of undergoing the treatment and what their expectations of medically assisted nutrition are.
Medically assisted nutrition can be performed via a tube inserted into any part of the gastrointestinal system (enteral) or via a tube inserted into the venous system (parenteral). There is some controversy and views vary on the ethics of medically assisted nutrition (Casarett 2005). The first ethical controversy centres on whether medically assisted nutrition is a medical intervention or a basic provision of comfort. Second, there is controversy as to how and by whom decisions should be made with regards to medically assisted nutrition in patients who no longer have the capacity to make decisions for themselves. This review will concentrate on assessing the benefit of provision of nutrition with medical assistance versus the harm caused by such intervention in palliative care patients. It is only with this information that clinicians and patients can make informed decisions about whether this type of intervention is beneficial or harmful to an individual patient.
A separate Cochrane review has been conducted considering the provision of medically assisted hydration for palliative care patients (Good 2014).
Objectives
To determine the effect of medically assisted nutrition on the QoL and length of life of palliative care patients.
Methods
Criteria for considering studies for this review
Types of studies
All relevant randomised controlled studies (RCTs) or prospective controlled studies (if no RCTs were found).
Types of participants
Participants included:
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palliative care participants who received medically assisted nutrition;
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patients receiving palliative care (WHO 2005);
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(but not be limited to) incurable cancer, dementia, neurodegenerative diseases (e.g. motor neuron disease), human immunodeficiency virus, chronic airways limitation and chronic heart failure whose prognosis was limited and the focus of care was QoL (Doyle 2004);
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adults aged 18 years and above, both male and female and in any setting such as home, hospice or hospital.
We did not limit included participants to those in the terminal phase of their illness. We excluded participants who were having medically assisted nutrition as part of a perioperative, chemotherapy or radiotherapy regimen, or because of chemotherapy or radiotherapy adverse effects.
Types of interventions
Medically assisted administration of nutrition
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Parenteral nutrition ‐ administration of nutritional liquid via a central or peripheral venous catheter that does not directly enter the gastrointestinal system.
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Enteral nutrition ‐ administration of nutritional liquid through a tube via the gastrointestinal system (nasogastric tube, jejunostomy, gastrostomy).
Comparisons
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Placebo.
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No intervention.
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Usual treatment or supportive care.
Types of outcome measures
Primary outcomes
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QoL on any measure (including symptom assessment scales).
Secondary outcomes
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Survival.
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Adverse events.
Search methods for identification of studies
Electronic searches
We searched the following electronic databases using a search strategy developed for MEDLINE, but modified appropriately for each database. The search strategies can be found in Appendix 1.
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Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library)(Issue 2, 2014, ).
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MEDLINE (Ovid) 1966 to 25/03/2014.
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EMBASE (Ovid) 1980 to 25/03/2014.
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SCIENCE CITATION INDEX (ISI Web of Science) (1900 to March 2014).
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CINAHL (EBSCO) (1982 to March 2014).
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CANCERLIT (up to February 2008).
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Caresearch ‐ database listing conference proceedings and grey literature (up to February 2008).
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Dissertation abstracts (up to February 2008).
Date of most recent search: March 2014.
Searching other resources
Reference lists
We searched the reference lists of all eligible trials, key textbooks and previous systematic reviews for additional studies.
Language
The search attempted to identify all relevant studies irrespective of language. We found no non‐English papers.
The subject search used a combination of controlled vocabulary and free‐text terms based on the search strategy for searching MEDLINE. Please see Appendix 1 for the search strategies used for each database.
We adapted this search strategy for other databases searched.
Data collection and analysis
Selection of studies
The original search was performed in July 2008. Subsequent searches were performed in April 2013 and March 2014 for the update of this review.
After review of the title and abstracts, nine references were retrieved in full. None of these studies met the inclusion criteria. However, there was one new prospective non‐controlled trial.
Data extraction and management
Data extraction
We planned to obtain the following information for each study:
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study methods (study design, allocation, blinding, setting, inclusion criteria);
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participants (sample size, exclusions/inclusions, number, disease, duration of trial, withdrawals and dropouts, site ‐ e.g. hospital, hospice, home);
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intervention (type, route of delivery, control used);
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outcome (QoL, symptom measures, survival, time from death intervention was initiated);
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adverse effects.
Two review authors planned to extract the data independently.
Quality
We planned to assess the methodological quality of all included trials using two scales. We would have assessed:
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RCTs via the Oxford Quality Scale devised by Jadad et al (Jadad 1996);
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non‐RCTs using a scale devised by Rinck et al (Rinck 1997).
Data analysis
We would have assessed the overall effectiveness of medically assisted nutrition in palliative care participants and undertaken a specific subgroup analysis (where possible)by:
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study design:
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data from RCTs and prospective controlled studies were to be evaluated separately;
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participants:
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cancer,
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non‐cancer,
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dementia,
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neurodegenerative diseases;
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intervention:
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medically assisted nutrition ‐ parenteral, enteral nutrition;
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study quality;
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timing of intervention (in relation to death);
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site.
Statistical analysis
We identified no studies that were suitable for evaluation.
Results
Description of studies
No studies met the inclusion criteria. Please see Figure 1 for details of the study selection process.
Study flow diagram.
Excluded studies
Please see Table 1 and the Characteristics of excluded studies table.
| Study ID | Methods | Participants | Interventions | Outcomes | Notes |
| Prospective, observational study | 69 adults with cancer | HPN | Median survival was 4 months, after participants began HPN. | ||
| Prospective, observational study | 28 patients with incurable cancer and gastrointestinal obstruction, treated at a tertiary hospital in Israel, referred to a multidisciplinary committee to consider HPN therapy | HPN therapy | Median survival was 140 days (range 20‐783) Survival varied according to KPS: KPS > 50 median survival 211 (range 50‐783) KPS < 50 median survival 62 (range 20‐141), P value < 0.01 Complications: sepsis (n = 6), bone pain (n = 1), hyperkalaemia (n = 1) | ||
| Cochrane systematic review | Motor neuron disease | Medically assisted nutrition (via enteral tube feeding) | There were no RCTs found. The review discussed 11 studies. There were 3 prospective studies and 8 retrospective studies. All 11 studies tested for survival advantage of intervention. 4 found a longer survival in participants who had a PEG, while the other 7 found no difference. Only 3 studies examined nutritional outcomes and these suggested a positive advantage for those participants with PEGs. Only 2 studies considered QoL, and both showed no improvement in QoL after PEG insertion | ||
| Prospective, cohort study. | 182 eligible participants ‐ 99 consented to inclusion in study ‐ family conflict (n = 3) and ‐ transferred/discharged/died (n = 5) | Of the 99 study participants, 82 had no feeding tube on admission (2 admitted for insertion of feeding tube). Of these 82 participants, 51 had a PEG inserted during the index admission | The median survival was not significantly different between those participants with PEG inserted (median 195 days, range 21 to 1405), and participants without PEG insertion (median 189 days, range 4 to 1502) (P value = 0.9) | ||
| Qualitative study | 13 participants were interviewed and 11 family members, during 2000 to 2001, in Sweden. These were recruited via AHCT nurses who were asked to contact participants with advanced cancer. Participants contacted were asked to provide names of relatives who were also willing to participate | 9 participants received partial HPN and oral intake, 2 received total HPN and 2 were actually weaned from HPN. The intervention consisted of HPN for at least 2 weeks (and at least 3 times per week), with an AHCT nurse connecting and disconnecting the infusion each time. 10 of the participants died within 6 months of the interview, but 11 lived more than 3 months | The positive features (according to participants and relatives) included assurance that nutrition was being met, and this led to a perceived benefit on QoL, energy, strength and activity. It was also seen as decreasing the feeling of "pressure to eat" and more acceptance of whatever could be eaten orally. The benefits of HPN were very much related to the close involvement and frequent visits of the AHCT nurses | The selection protocol used lends itself to be a large source of bias | |
| Prospective survey | Italian advanced cancer patients. Participants were included if they had hypophagia (oral calorie intake absent or < 50% of basal energy expenditure (Harris‐Benedict formula), life expectancy > 6 weeks, suitable participant and family circumstances (controlled or absent pain, no severe vital organ failure, emotional stability, willingness and ability to cope with HAN‐related activities and suitable hygienic conditions), and able to give verbal consent Of the 587, 164 were eligible and received HAN ‐ 135 HEN, 29 HPN The reasons for exclusion of the 423 participants included absence of hypophagia (n = 264), estimated life expectancy < 6 weeks, lack of suitable home/family conditions (n = 30) and lack of consent (n = 21) 50 participants (30%) aware of their diagnosis | The method of intervention for 135 participants with HEN was using an NG tube (50%), PEG (18%), jejunostomy (27%) and surgical gastrostomy (5%). The infusion method was pump (83%) and via gravity (17%). | Mean survival was 17.2 weeks for participants on HEN and 12.2 weeks for participants on HPN. This included 47 participants (29%) who survived less than 6 weeks. This was most common in groups with the primary tumour outside the gastrointestinal tract and head‐neck region, and in the group with a KPS ≤ 40. During the first month of HAN the KPS increased in 13 participants, decreased in 19 participants and was unchanged in 132 participants. 12 participants on HEN became able to go out and look after themselves unaided, while 2 became housebound. Body weight increased in 43 participants, decreased in 21 participants and there was no change in 80 participants ‐ with 20 participants confined to bed and unable to be weighed. Of the 108 participants excluded because their estimated survival was < 6 weeks, 31 (29%) lived ≥ 6 weeks. During treatment, there were 95 participants (61%) who underwent 155 hospital re‐admissions. This included 3 admissions for HPN complications and 7 for jejunostomy positioning |
AHCT: advanced home care team; DVT: deep vein thrombosis; HAN: home artificial nutrition; HEN: home enteral nutrition; HPN: home parenteral nutrition; KPS: Karnofsky Performance Status; NG: nasogastric; PEG: percutaneous endoscopic gastrostomy; QoL: quality of life; RCT: randomised controlled trial.
Risk of bias in included studies
We evaluated no studies for methodological quality.
Effects of interventions
We identified no RCTs or prospectively controlled trials that met the inclusion criteria.
Discussion
The objective of this systematic review was to determine the effectiveness of medically assisted nutrition in palliative care patients (of all ages) on their QoL and length of life. Extensive searching of the literature produced no RCTs or prospective controlled trials that fulfilled the inclusion criteria. The discussion will focus only on prospective trials that were retrieved, as this represents the next highest study quality design. However, the studies are all of a low quality because of their design, and therefore caution is needed in interpreting any of the results.
This updated search identified five prospective non‐controlled trials (including one qualitative study) that studied medically assisted nutrition in palliative care participants (Bozzetti 2002; Chermesh 2011; Meier 2001; Orrevall 2005; Pironi 1997), and one updated Cochrane systematic review (Katzberg 2011). One study included participants with advanced dementia (Meier 2001). The other four studies included only participants with advanced cancer (Bozzetti 2002; Chermesh 2011; Orrevall 2005; Pironi 1997). In three studies, participants received only parenteral nutrition (Bozzetti 2002; Chermesh 2011; Orrevall 2005), while in another two studies, the included participants had enteral nutrition (Katzberg 2011; Meier 2001). In one study, included participants received either enteral or parenteral nutrition (Pironi 1997). The Cochrane review assessed participants with motor neuron disease, but found no RCTs (Katzberg 2011).
Survival was measured in four studies (Bozzetti 2002; Chermesh 2011; Meier 2001; Pironi 1997), and evaluated in the systematic review (Katzberg 2011). QoL was used as an outcome measure in three of the studies (Bozzetti 2002; Katzberg 2011; Orrevall 2005). Two studies determined the effect of the intervention on the Karnofsky Performance Scale (KPS) (Bozzetti 2002; Pironi 1997). Two studies recorded adverse events of the interventions (Chermesh 2011; Pironi 1997). The qualitative study analysed the positive and negative features according to the themes derived from the data (Orrevall 2005).
In one prospective, cohort study of participants with advanced dementia, there was no significant difference in survival between participants with percutaneous endoscopic gastrostomy (PEG) inserted (median 195 days, range 21 to 1405 days), and participants without PEG insertion (median 189 days, range four to 1502) (P value = 0.9) (Meier 2001). The Cochrane review had conflicting results, in that four studies (two prospective and two retrospective) found a longer survival in participants who had a PEG, while the other seven studies (one prospective and six retrospective) found no difference (Katzberg 2011). Bozzetti 2002 found that participants on home parenteral nutrition (HPN) had a median survival of four months (range one to 14), while Chermesh 2011 found the median survival for patients on HPN was 140 days (range 20 to 783). There was a significant difference in survival between participants with a better performance status (KPS > 50; median survival 211 days) compared with participants with a worse performance status (KPS < 50; median survival 62 days). The mean survival was used when Pironi 1997 considered participants on HPN (12.2 weeks) and participants on home enteral nutrition (HEN) (17.2 weeks). QoL did not improve after PEG insertion for participants with motor neuron disease (Katzberg 2011), or at one month in people with advanced cancer (Bozzetti 2002). There was a perceived benefit in QoL in the qualitative study (Orrevall 2005). In one study, the KPS was stable until a progressive decline at three months prior to death (Bozzetti 2002), while another study found that at one month after intervention the KPS was increased in 13 participants, decreased in 19 participants, and unchanged in 132 participants (Pironi 1997). The qualitative study of people with advanced cancer in Sweden found that HPN produced positive features including assurance that nutrition was being met, and this led to a perceived benefit on energy, strength and activity (Orrevall 2005). It was also seen as decreasing the feeling of "pressure to eat" and more acceptance of whatever was able to be eaten orally.
Pironi 1997 found that with HEN, there was nasogastric tube blockage/dislodgment in 0.26 per year of HEN and PEG site infection in one participant and hub replacement in two participants, while the complications of treatment with HPN (per year of treatment) were catheter sepsis (0.67), deep vein thrombosis (DVT) (0.16) and metabolic instability (0.50). This study also attempted to assess the burden of medically assisted nutrition for participants and their families. However, this was only done as a judgement by nutrition staff, and was therefore open to a large element of bias. They found that medically assisted nutrition was well accepted in 124 cases (19 HPN), with annoyance in 30 cases (seven HPN) and scarcely tolerated in 10 cases (three HPN). In the study by Chermesh 2011, eight out the 28 patients (29%) had total parenteral nutrition (TPN)‐related complications. Six patients had line sepsis, one patient had bone pain (likely to be from the TPN solution) and one patient had hyperkalaemia. The qualitative study found that the negative features of HPN were related to physical symptoms of nausea, vomiting, drowsiness and headache, as well as HPN placing a restriction on their family life and social involvement (Orrevall 2005).
| Study ID | Methods | Participants | Interventions | Outcomes | Notes |
| Prospective, observational study | 69 adults with cancer | HPN | Median survival was 4 months, after participants began HPN. | ||
| Prospective, observational study | 28 patients with incurable cancer and gastrointestinal obstruction, treated at a tertiary hospital in Israel, referred to a multidisciplinary committee to consider HPN therapy | HPN therapy | Median survival was 140 days (range 20‐783) Survival varied according to KPS: KPS > 50 median survival 211 (range 50‐783) KPS < 50 median survival 62 (range 20‐141), P value < 0.01 Complications: sepsis (n = 6), bone pain (n = 1), hyperkalaemia (n = 1) | ||
| Cochrane systematic review | Motor neuron disease | Medically assisted nutrition (via enteral tube feeding) | There were no RCTs found. The review discussed 11 studies. There were 3 prospective studies and 8 retrospective studies. All 11 studies tested for survival advantage of intervention. 4 found a longer survival in participants who had a PEG, while the other 7 found no difference. Only 3 studies examined nutritional outcomes and these suggested a positive advantage for those participants with PEGs. Only 2 studies considered QoL, and both showed no improvement in QoL after PEG insertion | ||
| Prospective, cohort study. | 182 eligible participants ‐ 99 consented to inclusion in study ‐ family conflict (n = 3) and ‐ transferred/discharged/died (n = 5) | Of the 99 study participants, 82 had no feeding tube on admission (2 admitted for insertion of feeding tube). Of these 82 participants, 51 had a PEG inserted during the index admission | The median survival was not significantly different between those participants with PEG inserted (median 195 days, range 21 to 1405), and participants without PEG insertion (median 189 days, range 4 to 1502) (P value = 0.9) | ||
| Qualitative study | 13 participants were interviewed and 11 family members, during 2000 to 2001, in Sweden. These were recruited via AHCT nurses who were asked to contact participants with advanced cancer. Participants contacted were asked to provide names of relatives who were also willing to participate | 9 participants received partial HPN and oral intake, 2 received total HPN and 2 were actually weaned from HPN. The intervention consisted of HPN for at least 2 weeks (and at least 3 times per week), with an AHCT nurse connecting and disconnecting the infusion each time. 10 of the participants died within 6 months of the interview, but 11 lived more than 3 months | The positive features (according to participants and relatives) included assurance that nutrition was being met, and this led to a perceived benefit on QoL, energy, strength and activity. It was also seen as decreasing the feeling of "pressure to eat" and more acceptance of whatever could be eaten orally. The benefits of HPN were very much related to the close involvement and frequent visits of the AHCT nurses | The selection protocol used lends itself to be a large source of bias | |
| Prospective survey | Italian advanced cancer patients. Participants were included if they had hypophagia (oral calorie intake absent or < 50% of basal energy expenditure (Harris‐Benedict formula), life expectancy > 6 weeks, suitable participant and family circumstances (controlled or absent pain, no severe vital organ failure, emotional stability, willingness and ability to cope with HAN‐related activities and suitable hygienic conditions), and able to give verbal consent Of the 587, 164 were eligible and received HAN ‐ 135 HEN, 29 HPN The reasons for exclusion of the 423 participants included absence of hypophagia (n = 264), estimated life expectancy < 6 weeks, lack of suitable home/family conditions (n = 30) and lack of consent (n = 21) 50 participants (30%) aware of their diagnosis | The method of intervention for 135 participants with HEN was using an NG tube (50%), PEG (18%), jejunostomy (27%) and surgical gastrostomy (5%). The infusion method was pump (83%) and via gravity (17%). | Mean survival was 17.2 weeks for participants on HEN and 12.2 weeks for participants on HPN. This included 47 participants (29%) who survived less than 6 weeks. This was most common in groups with the primary tumour outside the gastrointestinal tract and head‐neck region, and in the group with a KPS ≤ 40. During the first month of HAN the KPS increased in 13 participants, decreased in 19 participants and was unchanged in 132 participants. 12 participants on HEN became able to go out and look after themselves unaided, while 2 became housebound. Body weight increased in 43 participants, decreased in 21 participants and there was no change in 80 participants ‐ with 20 participants confined to bed and unable to be weighed. Of the 108 participants excluded because their estimated survival was < 6 weeks, 31 (29%) lived ≥ 6 weeks. During treatment, there were 95 participants (61%) who underwent 155 hospital re‐admissions. This included 3 admissions for HPN complications and 7 for jejunostomy positioning | ||
| AHCT: advanced home care team; DVT: deep vein thrombosis; HAN: home artificial nutrition; HEN: home enteral nutrition; HPN: home parenteral nutrition; KPS: Karnofsky Performance Status; NG: nasogastric; PEG: percutaneous endoscopic gastrostomy; QoL: quality of life; RCT: randomised controlled trial. | |||||
