Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial
Abstract
OBJECTIVE
Preventing loss of muscle mass and function is an enduring challenge in malnourished patients with incurable cancer. The benefit of supplemental home parenteral nutrition has not been firmly established. Our aim was to evaluate the effects of supplemental home parenteral nutrition, the primary endpoint being fat free mass (FFM) and secondary: muscle function, quality of life and overall survival.
DESIGN AND METHODS
In a single centre open-label randomised controlled trial, patients with incurable gastrointestinal cancer, nutritionally at risk, were randomly assigned to either; a) best practice nutritional care and dietetic counselling (non-sHPN) or b) dietetic counselling and supplemental home parenteral nutrition (sHPN group). Treatment duration was 24 weeks with visits every six weeks for five scheduled visits. Main outcome was gain in bioelectrical impedance analyses (BIA) estimated FFM. Secondary outcomes were muscle strength, quality of life and survival.
RESULTS
Eligible for inclusion were 234 patients, 47 of these accepted enrolment; 25 were randomized to non-sHPN and 22 to sHPN according to performance status, age and diagnoses. Median age was 66.9 (41.5-88.2), BMI 21.3 (14.8-35.7) and (91%) were receiving palliative chemotherapy. Median FFM and fat free mass index increased in the sHPN group. At 12 weeks a significant difference (p < 0.01) was found between the groups; in the sHPN group 69% of the patients (versus 40%) increased their FFM. Handgrip…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 234 participants or records.
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