Speaker
Description
Older adults, who represent nearly half of new cancer diagnoses in France, remain largely underrepresented in phase I trials (<7%). Functional decline and frailty are key barriers to their participation. The primary purpose of the ENERGY study is to determine whether a multimodal intervention combining exercise, nutritional management, and psychological support can improve inclusion and retention rates of cancer patients aged ≥70 years in phase I clinical trials. The main hypothesis is that enhancing patients’ physical function, nutritional status, and psychological resilience will increase their eligibility for, and adherence to, experimental treatments. The ENERGY trial consists of two sequential phases. The first is a pilot study assessing the feasibility and implementation of the multimodal intervention in 10 patients. The second phase is an open-label, randomized (1:1), multicenter controlled trial comparing the intervention group with standard care across 10 French centers accredited for early-phase oncology trials. A total of 196 patients aged ≥70 years, treated for cancer and enrolled in a phase I clinical trial, will be included. Participants will undergo physical, nutritional, and psychological assessments at baseline and at 1, 2, and 3 months. The intervention group will receive a 3-month combined program of exercise, nutritional management, and psychological support, the specific modalities of which will be refined through patient and caregiver input during the pilot phase. The control group will receive standard care. Quantitative analyses will evaluate feasibility, adherence, and the program’s impact on functional outcomes and trial inclusion/retention rates. As recruitment has not yet started, no data are available at this stage. The presentation will therefore describe the study protocol and planned analyses. The study’s originality lies in its pragmatic, home-based multimodal design integrating exercise, nutrition, and psychological support within early-phase oncology trials for older adults.
Keywords
geriatric oncology ; early-phase clinical trials ; exercise ; nutritional and psychological support
| Abstract submitters declaration | yes |
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| Conflict of Interest & Ethical Approval | yes |
