RecruitingNot Applicable

Weight Management in Obese Cancer Patients During Curative Active Treatment

Spain50 participantsStarted 2025-07-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accrual

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Retention

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Fidelity of the programme delivery

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Nutritional adherence

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Physical activity adherence

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Ocurrance of any serious or life-threatening adverse events (Safety)

Timeframe: Throughout the study period (from baseline to end of intervention, 3 to 9 months)

Trial details

NCT IDNCT07058207

SponsorInstitut d'Investigació Biomèdica de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Lorena Arribas

+34932607751 larribas@iconcologia.net

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Accrual

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Retention

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Fidelity of the programme delivery

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Nutritional adherence

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Physical activity adherence

Timeframe: From baseline to end of cancer treatment (3 to 9 months)

Ocurrance of any serious or life-threatening adverse events (Safety)

Timeframe: Throughout the study period (from baseline to end of intervention, 3 to 9 months)