Weight management during curative treatment for adults with obesity and solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.