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Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study
This is a feasibility study intervention to fifty cancer patients with obesity and with newly diagnosed stage II-IV solid tumors undergoing curative treatment recruited at the Catalan Institute of Oncology (ICO) in L'Hospitalet, Spain. The investigators hypothesize that weight management during cancer treatment could enhance health outcomes for this population. The feasibility of a multimodal weight loss management program will be assesses, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support.
The single-arm intervention will consist of a multimodal weight management program, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support. Hypocaloric diet will be individualized according to their energy requirements estimated and then applying a 20% caloric restriction. In order to reduce body weight and maintain muscle mass, a high-protein diet will be provided consisting of 1.5 g of protein/kg/day. Participants will be provided with a 3-day food record (3-DFR) chart prior to their baseline visit. After a full nutritional evaluation, the dietitian will create a diet plan unique to the participant. For those participants struggling to attain their recommended intake or anticipating protein intake to be challenging, an oral whey powder supplement will be provided for the duration of the study. Additional approaches to overcoming dietary challenges will include information/resources on nutritional symptom management that can impact dietary intake and/or high-protein recipes. The exercise program will be based on supervised aerobic and resistance exercise home-based training sessions 3 times/week. The sessions will be 60 minutes long and will include 5 minutes of flexibility, followed by 25 minutes of aerobic exercises, 25 minutes of resistance exercises, and 5 minutes of balance exercises. The physiotherapist will supervise the sessions and will provide monthly individual face-to-face counselling to assure adherence to the protocol. The investigators have designed an individualized exercise program that fits the current patient's clinical situation. Each patient will receive a fitness tracker band to monitor his/her activity. Behavioural support will include problem-solving strategies and practical tools to facilitate participants' self-control on emotional eating or stress-driven behaviours. Targeted behaviour goals will be set. A psychologist will provide technical support and training to the dietitian and the physiotherapist to improve their skills to provide behavioural changes and motivation.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Institut Català d'Oncologia. Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, Spain
Start Date
July 22, 2025
Primary Completion Date
August 1, 2026
Completion Date
March 1, 2027
Last Updated
July 28, 2025
50
ESTIMATED participants
Multimodal weight management program
BEHAVIORAL
Lead Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
NCT06311214
NCT04704661
Data Source & Attribution
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