ABSTRACT
BACKGROUND: Beta-hydroxy-beta-methylbutyrate (HMB) is a nutrition supplement that may attenuate muscle wasting from critical illness. This trial aimed to determine feasibility of administering a blinded nutrition supplement in the intensive care unit (ICU) and continuing it after ICU discharge. METHODS: Single-center, parallel-group, blinded, placebo-controlled, randomized feasibility trial. After traumatic injury necessitating admission to ICU, participants were randomized to receive an enteral study supplement of 3 g of HMB (intervention) or placebo daily for 28 days or until hospital discharge. Primary outcome was feasibility of administering the study supplement, quantified as protocol adherence. Secondary outcomes included change in quadriceps muscle thickness, measured weekly until day 28 or hospital discharge by using ultrasound and analyzed by using a linear mixed model. RESULTS: Fifty randomized participants (intervention, n = 26; placebo, n = 24) showed comparable baseline characteristics. Participants received 862 (84.3%) of the 1022 prescribed supplements during hospitalization with 543 (62.8%) delivered via an enteral feeding tube. The median (IQR) number of study supplements successfully administered per participant was 19.5 (13.0-24.0) in the intervention group and 16.5 (8.5-23.5) in the placebo group. Marked loss of quadriceps muscle thickness occurred in both groups, with the point estimate favoring attenuated muscle loss with the intervention, albeit with wide CIs (mean intervention difference after 28 days, 0.26 cm [95% CI, -0.13 to 0.64]). CONCLUSION: A blinded, placebo-controlled, randomized clinical trial of daily enteral HMB supplementation for up to 28 days in hospital is feasible. Any effect of HMB supplementation to attenuate muscle wasting after traumatic injury remains uncertain.
Subject(s)
Muscle, Skeletal , Valerates , Humans , Pilot Projects , Muscle, Skeletal/physiology , Valerates/pharmacology , Valerates/therapeutic use , Dietary Supplements , Muscular AtrophyABSTRACT
BACKGROUND: The purpose of this study was to determine if p16 status, chemotherapy regimen, or other nutrition markers could improve protocol accuracy in predicting proactive gastrostomy in patients with head and neck cancer. METHODS: Patients who received curative treatment from July 2010 to June 2011 were included (n = 269). Associations among dependent variables (age, sex, tumor site, staging, treatment, p16 status, albumin, and Malnutrition Screening Tool [MST] score), the protocol risk rating, and requirement for proactive gastrostomy were examined. RESULTS: Current protocol correctly identified 81 of 88 high-risk patients (92%) for gastrostomy, but incorrectly classified 32 of 181 low-risk patients (18%). Analysis of low-risk patients with oral or oropharyngeal cancers, found p16-positive disease had 4.4 times greater odds (p = .049), and those at risk of malnutrition had 4.5 times greater odds (p = .019) of requiring gastrostomy. CONCLUSION: Malnutrition risk and p16 status could be used to identify further patients who may benefit from proactive gastrostomy. © 2017 Wiley Periodicals, Inc. Head Neck 39: 868-875, 2017.