METHODS/DESIGN: This open-labelled, randomised controlled trial (RCT) will randomly allocate patients into intervention and control groups. Ambulated Malaysian aged over 18 years and scheduled for elective surgery for (suspected) GC, will be included in this study. The intervention group will be given whey-protein-infused carbohydrate-loading drinks on the evening before their operation and 3 h before their operation as well as started on early oral feeding 4 h post-operatively. The control group will be fasted overnight pre-operation and only allowed plain water, and return to a normal diet is allowed when bowel sounds return post-operatively. The primary outcomes of study are length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function. Additional outcome measures are changes in nutritional status, biochemical profile and functional status. Data will be analysed on an intention-to-treat basis.
TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03667755. Retrospectively registered on 12 September 2018; Protocol version: version 3 dated 27 September 2017.
METHODS: Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate.
DISCUSSION: This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes.
TRIAL REGISTRATION: ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered.
SUBJECTS: A total of 32 healthy males (Mean±SD), aged 59.7±6.3 years, with a BMI of 26.7±2.2 kg/m2 were recruited to the study.
METHOD: Participants were randomized to either the FCR group (and were instructed to follow a calorie restricted dietary regime with intermittent fasting) or to the control group (in which individuals were asked to maintain their current lifestyle), for a 3 month period. Mood was assessed using the Profile of Mood States and depression was assessed using Beck Depression Inventory-II and Geriatric Depression Scale-15 at baseline, week 6 and week 12 of the intervention.
RESULTS: A total of 31 subjects completed the study (n=16, FCR and n=15, control). Significant decreases in tension, anger, confusion and total mood disturbance and improvements in vigor were observed in participants in the FCR group compared to the control group (p<0.05). No significant changes in mean depression scores were observed. Weight, BMI and percent body fat were reduced by 3.8%, 3.7% and 5.7% respectively in the FCR group.
CONCLUSIONS: Our findings show that a FCR dietary regime is effective in improving mood states and nutritional status among ageing men.
METHODOLOGY: A prospective comparison of subjective global assessment (SGA), and anthropometry (mid-arm muscle circumference, MAMC; triceps skinfold thickness, TST) between elderly stroke patients on long-term NG feeding and matched controls was performed. Selected clinicians and carers of patients were interviewed to assess their knowledge and attitudes to gastrostomy feeding.
RESULTS: 140 patients (70 NG, 70 oral) were recruited between September 2010 and February 2011. Nutritional status was poorer in the NG compared to the oral group (SGA grade C 38.6% NG vs 0% oral, p<0.001; TST males 10.7 + 3.7 mm NG vs 15.4 + 4.6 mm oral, p<0.001; MAMCmales 187.9 + 40.4 mm NG vs 228.7 + 31.8 mm oral, p<0.001). 45 (64.3%) patients on long-term NG feeding reported complications, mainly consisting of dislodgement (50.5%), aspiration of feed content (8.6%) and trauma from insertion (4.3%). Among 20 clinicians from relevant speciliaties who were interviewed, only 11 (55%) clinicians would routinely recommend a PEG. All neurologists (100%) would recommend a PEG, whilst the response was mixed among non-neurologists. Among carers, lack of information (47.1%) was the commonest reason stated for not choosing a PEG.
CONCLUSION: Elderly patients with stroke on long term NG feeding have a poor nutritional status. Lack of recommendation by clinicians appears to be a major barrier to PEG feeding in these patients.