Resistance training and protein supplementation in patients with incurable gastroesophageal cancer: a randomized feasibility trial.
Verbatim Formal Study Abstract
Cancer cachexia is associated with reduced physical performance, quality of life, and survival in patients with incurable gastroesophageal cancer. Resistance training and protein supplementation have the potential to improve these outcomes. Whether an intervention comprising resistance training and protein supplementation is feasible during treatment for incurable gastroesophageal cancer is not known.
This was an open-label, parallel-group, two-arm, randomized controlled feasibility trial. Patients with incurable gastroesophageal cancer scheduled to undergo first-line chemotherapy were randomized 2:1 to resistance training three times per week and daily protein supplementation or to control. The primary outcome, feasibility, was assessed by recruitment, retention, adherence, and harms. Secondary outcomes included body composition, physical performance, quality of life, and treatment tolerability.
Out of 106 potentially eligible patients, 20 participants (5 female and 15 male, mean age 65) were randomized yielding a recruitment rate of 19%. 18 participants completed the trial with a retention rate of 90%. Median (25th; 75th percentile) adherence to the resistance training sessions and to the protein supplements was 63% (43; 77) and 39% (17; 76), respectively. Five participants (38%) met the minimum feasibility criteria of both interventions. No serious adverse events related to the intervention occurred. We found no between-group differences in body composition, physical performance, quality of life, or treatment tolerability.
Resistance training combined with protein supplementation was not feasible during first-line chemotherapy in patients with incurable gastroesophageal cancer due to low accrual and low adherence to protein supplementation.
ClinicalTrials.gov NCT05650827. Study registration date 2022-12-12.