💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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