RecruitingNot ApplicableNCT07058207

Weight Management in Obese Cancer Patients During Curative Active Treatment

Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study

Sponsor

Institut d'Investigació Biomèdica de Bellvitge

Enrollment

50 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Solid Neoplasm Curative Treatment Stage II-IV

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Adult (age 18+) with pathologically confirmed malignant solid tumors, stage II-IV, elected for oncological treatment (chemo, radio, or both) with curative intend.
Expected oncological treatment time ≥ 3 months.
BMI ≥ 30 kg/m²
Resident in the Barcelona area up to the completion of cancer treatment.
ECOG Perfomance Status (PS) 0-1
Availability of internet access.

Exclusion Criteria13

Patients with melanoma and brain tumours.
Surgery as the only treatment.
Tumour localizations with high risk of malnutrition (such as head and neck, upper gastrointestinal tract, or pancreatic cancer):
Pregnancy or breastfeeding
Another active malignancy
Current health or medical condition that affects weight status, e.g., untreated hyper- or hypothyroidism,etc
Pre-existing medical condition that precludes adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-months.
Unable to read or understand Spanish or Catalan
Enrolled in a weight loss program
Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
Use of pacemaker or another electrical implanted device
History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
Patients with any concurrent medical or psychological condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.

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Interventions

BEHAVIORALMultimodal weight management program

This intervention consists of three components: * Nutritional Counseling: * A personalized hypocaloric and high-protein diet is prescribed, based on individual energy requirements with a 20% caloric reduction. * The protein intake target is 1.5 g/kg/day to promote fat loss while maintaining muscle mass. * Exercise Program * Home-based, supervised aerobic and resistance training sessions conducted 3 times per week. * Each 60-minute session includes: 5 minutes flexibility, 25 minutes aerobic training, 25 minutes resistance training, and 5 minutes balance exercises. * Behavioral Support * Patients receive training in problem-solving strategies, motivation, and emotional self-regulation to improve adherence to both dietary and exercise goals. * Health professionals delivering the intervention are trained in behavior change techniques by a clinical psychologist.