Geriatric Oncology multidomain intervention study to prevent Cognitive impairment among older Indian patients with cancer receiving chemotherapy: a multicentric randomised controlled trial (GOCog)

Chemotherapy-related cognitive dysfunction is a common adverse effect in older adults receiving cancer-directed therapy, impairing independence, treatment adherence, and quality of life. Evidence from India is limited, and culturally adapted interventions are lacking. We aim to assess (i) the effectiveness of a multidomain intervention (exercise and cognitive training) on cognition, function, and quality of life; (ii) the feasibility and compliance to the intervention; and (iii) exploratory imaging and biomarker correlates. We will conduct a multicentric randomised controlled trial with two parallel arms among patients ≥ 60 years planned for systemic chemotherapy at Tata Memorial Centre (Mumbai) and Medical Trust Hospital (Kochi). A total of 364 participants will be randomised 1:1 to the intervention group (exercise + cognitive training) or control group (usual care). The intervention will consist of a 3-month program combining supervised and home-based aerobic, resistance exercises and structured cognitive training activities. The primary endpoint will be the difference in the mean change in cognition from baseline to end of study between the two arms, as measured by FACT-Cog. Secondary endpoints will include objective cognition, depression, function, fatigue, quality of life, progression-free survival, and overall survival. Tertiary endpoints will include FDG-PET imaging and biomarker analysis. Outcomes will be assessed at baseline and 3 months. Compliance will be monitored via patients’ diaries and step counts, as recorded by wearables (when feasible). This study will provide the first randomised evidence from India on the efficacy and feasibility of a multidomain intervention for chemotherapy-related cognitive dysfunction in older patients with cancer. Findings will help improve the tolerability of chemotherapy in older patients with cancer, inform survivorship care models particularly in low- and middle-income countries and contribute to international guidelines. Clinical Trials Registry-India (CTRI/2023/12/060849). Registered prospectively on 27 December 2023.