Exercise therapy in survivors of gastroesophageal cancer: A phase I, randomized dose-finding study of an individually tailored, remotely supervised exercise intervention.

Abstract

TPS12169 Background: Advances in perioperative systemic therapy and surgery have extended survival for patients with locoregional gastroesophageal cancer (GEC). However, intensive multimodality treatment often causes substantial physical function decline, leading to loss of independence and poor quality of life. No evidence-based interventions are currently approved to prevent or reverse this decline. Although exercise can improve fatigue, quality of life, and functional outcomes in other malignancies, it remains poorly studied in survivors of GEC. In patients with colon cancer, exercise after treatment is feasible, improves quality of life, and alleviates anxiety and depression. More recently, the CHALLENGE randomized trial demonstrated that a structured, in-person, supervised exercise intervention after chemotherapy for early-stage colon cancer can improve physical function, decrease cancer recurrence, and increase survival versus health education alone. However, the in-person exercise intervention was limited by low adherence and lack of exercise dose optimization, with only one target dose tested. These findings may not generalize to survivors of GEC, where treatment is more intensive and surgery more morbid. In this patient population, we hypothesize that aerobic exercise up to 225 minutes per week will be feasible, but higher doses will lead to lower levels of relative exercise dose intensity (REDI), defined as the ratio of completed to prescribed exercise dose over the course of the intervention. Methods: This phase I, randomized dose-finding study will enroll 24 adults (age ≥18 years) with stage I-III GEC who completed perioperative systemic therapy within 12 months and are sedentary ( < 30 minutes/week of moderate-to-vigorous physical activity). Participants will be randomized 1:1:1 to one of three individually tailored, remotely supervised aerobic programs led by an exercise physiologist. Each 16-week program will target either 75 minutes (25 minutes, 3x/week), 140 minutes (35 minutes, 4x/week), or 225 minutes (45 minutes, 5x/week) of moderate-intensity exercise. Demographic and disease/treatment data will be collected at enrollment. Assessments at baseline and post-intervention include measures of cardiorespiratory fitness (submaximal exercise test), other measures of physical, cognitive, and psychological function, and quality of life. Heart rate, body weight/composition, and step count will be measured throughout using remote monitoring devices. The primary outcome is feasibility, as measured by the REDI. An exercise dose will be considered feasible if > 60% of the participants (≥5/8 per arm) achieve a REDI of > 75%. Secondary outcomes include changes in cardiorespiratory fitness and other functional and quality of life measures. This study has been IRB approved and is ongoing (NCI202600630). Clinical trial information: NCI202600630 .