Adherence to combined exercise and dietary intervention in patients with gastrointestinal cancer undergoing neo-adjuvant therapy: an open-label, pilot, randomized controlled trial.

Abstract BackgroundTo assess adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.MethodsParallel randomized controlled, open label, pilot trial. A table from a web based randomization system was used to allocate treatments. 46 patients were screened at diagnosis of esophageal, gastric, pancreatic and rectal cancer from June 2018 to November 2019 at a teaching hospital in Loures, 39 were randomized. A planned interim analysis was performed and results are herein presented. Patients were randomized to receive either 8 week individualized CEDI, with moderate aerobic and resistance training, dietary counseling and oral nutritional supplements or standard care. Follow up was conducted after neo-adjuvant treatment. Main outcome measures were adherence to CEDI, change in weight, body composition and functional status. Adherence to CEDI was analyzed with an intention to treat approach, other outcome measures were analyzed with a per protocol approach. Data analysis was conducted with Chi-square test or Fisher exact test and t-test or Mann Whitney U test. Effect size was computed with Cohen’s d for t tests and r for Mann-Whitney U tests. Paired-samples t test or Wilcoxon Signed Rank Test were used to analyze longitudinal data.Results39 patients (CEDI n = 19 or control n = 20) were randomized and included in the intention to treat analysis (29 (74.3%) male, median age 63.5 (Interquartile Range (IQR):11.75)). 32 patients completed follow up. 13/19 (68.4%) were fully adherent to CEDI. CEDI patients maintained weight (Effect size (EF):0.457; 95% Confidence Interval (95%CI): [0.44,0.46]), waist circumference (EF:-0.56, 95%CI: [-1.08, -0.034]), had a lower skeletal muscle loss (EF:-0.79; [-1.77;0.18]) and improved 6 minute walking test distance (EF:-1.51; 95%CI: [-2.57;-0.44]) and quality of life function score (EF:0.45; 95%CI:[0.43,0.45]). There were 4 serious adverse events, 3 in theintervention and 1 in the control arm but none related to the intervention.ConclusionsCEDI is feasible and patients are willing to participate even under neo-adjuvant chemoradiotherapy, resulting in potential nutritional and functional benefits.Trial registrationTrial registry: www.clinicaltrials.gov; Identifier: NCT05237921, 14-2-22, retrospectively registered, https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT05237921&cntry=&state=&city=&dist=