Weight management during curative treatment for adults with obesity and solid tumors
Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study
This program will try a personalized low-calorie, high-protein diet plus supervised home exercise and behavioral support for adults with obesity who are receiving curative treatment for stage II–IV solid tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT07058207 on ClinicalTrials.gov |
What this trial studies
This is a single-arm feasibility intervention enrolling 50 adults with BMI ≥30 and newly diagnosed stage II–IV solid tumors receiving curative-intent chemotherapy, radiotherapy, or both at the Catalan Institute of Oncology in L'Hospitalet, Spain. Participants follow a multimodal weight management program that combines a personalized hypocaloric diet (about 20% calorie restriction) with a high-protein target (~1.5 g/kg/day), plus a supervised home-based exercise plan three times weekly and behavioral support. A dietitian provides individualized meal plans and may supply whey protein supplements for participants who need help meeting protein goals, and a physiotherapist supervises exercise with monthly face-to-face counseling. The study measures feasibility and adherence during active oncologic treatment and collects data on weight, body composition, and functional measures.
Who should consider this trial
Good fit: Adults (≥18 years) with pathologically confirmed stage II–IV solid tumors, BMI ≥30 kg/m², ECOG 0–1, planned curative chemotherapy and/or radiotherapy for at least three months, resident in the Barcelona area, and with internet access are ideal candidates.
Not a fit: Patients with tumour sites at high risk of malnutrition (e.g., head and neck, upper GI, pancreatic), those having surgery only, patients with contraindications to unsupervised exercise, brain tumours or melanoma, pregnancy, other active malignancy, or medical conditions affecting weight are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help reduce excess weight while preserving muscle and improving treatment tolerance and overall health during curative cancer therapy.
How similar studies have performed: Prior trials of combined nutrition and exercise in cancer patients have shown benefits for muscle mass and function, but intentional weight-loss programs during curative treatment for obese patients are less studied and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Institut Català d'Oncologia. Catalan Institute of Oncology — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Lorena Arribas, PhD, MsC, RD — Catalan Institute of Oncology (ICO-Hospitalet). Bellvitge Biomedical Research Institute (IDIBELL)
- Study coordinator: Lorena Arribas
- Email: larribas@iconcologia.net
- Phone: +34932607751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.