JMIR Publications

ABSTRACT

Background:

Concurrent chemoradiotherapy (CCRT) for abdominal cancer frequently induces chemoradiotherapy‑induced muscle loss, weight loss, and malnutrition.

Objective:

This randomized phase II trial evaluated whether a multidisciplinary, mHealth‑based multimodal rehabilitation program could preserve handgrip strength and muscle mass in abdominal cancer patients undergoing CCRT.

Methods:

In this prospective, multicenter, randomized, open‑label phase II trial (NCT05325554), 111 eligible patients with abdominal malignancies scheduled for CCRT were randomly assigned (1:1) to receive either multidisciplinary mHealth rehabilitation care (MRC, n=57) or standard care (SC, n=54). The MRC program was delivered by a dedicated multidisciplinary team comprising oncologists, rehabilitation physicians, nurses, clinical nutritionists, and psychologists. Using the AINST mHealth platform and wearable heart rate monitors, the team provided coordinated, individualized exercise, nutritional, and psychological interventions based on weekly assessments and real‑time data. The SC group received routine oncology care. The primary endpoint was change in handgrip strength from baseline to CCRT completion. Secondary endpoints included body weight, skeletal muscle mass, nutritional biomarkers, quality of life, psychological status, and adverse events.

Results:

Between February 2022 and April 2023, 111 patients were enrolled. Adherence was high, with 83.9% (47/56) of MRC patients achieving preset exercise targets. Compared with SC, the MRC group demonstrated significantly less decline in handgrip strength at all time points (all p < 0.001). The MRC group also showed better preservation of body weight (mean difference 1.3 kg, p=0.005) and a significantly lower proportion of patients with >5% weight loss (10.7% vs. 32.7%, p=0.005). Skeletal muscle mass was also better preserved (mean difference 1.3 kg, p<0.001). The MRC group had less decline in serum albumin (p=0.009) and prealbumin (p=0.019), and lower incidences of ≥G3 leukopenia (5.4% vs. 19.2%, p=0.037) and ≥G1 thrombocytopenia (16.1% vs. 34.6%, p=0.026). Nutritional and psychological benefits persisted at 4‑week post‑CCRT follow‑up.

Conclusions:

A multidisciplinary, mHealth‑based multimodal rehabilitation program effectively preserves handgrip strength, muscle mass, and nutritional status while reducing treatment toxicity in abdominal cancer patients undergoing CCRT. The multicenter implementation using standardized digital tools supports its scalability and translation into real‑world clinical pathways. Clinical Trial: Clinical Trial Registration: ClinicalTrials.gov NCT05325554.Registration Date 03/08/2022.