NCT07058207 Weight Management in Obese Cancer Patients During Curative Active Treatment
| NCT ID | NCT07058207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-07-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lorena Arribas, PhD, MsC, RD
PRINCIPAL INVESTIGATOR
Catalan Institute of Oncology (ICO-Hospitalet). Bellvitge Biomedical Research Institute (IDIBELL)
Frequently Asked Questions
Who can join the NCT07058207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07058207 currently recruiting?
Yes, NCT07058207 is actively recruiting participants. Contact the research team at larribas@iconcologia.net for enrollment information.
Where is the NCT07058207 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT07058207 clinical trial?
NCT07058207 is sponsored by Institut d'Investigació Biomèdica de Bellvitge. The principal investigator is Lorena Arribas, PhD, MsC, RD at Catalan Institute of Oncology (ICO-Hospitalet). Bellvitge Biomedical Research Institute (IDIBELL). The trial plans to enroll 50 participants.
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