Weight Management in Obese Cancer Patients During Curative Active Treatment

Официальное название

Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study

Обзор

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.

Подробное описание

The single-arm intervention will consist of a multimodal weight management program, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support. Hypocaloric diet will be individualized according to their energy requirements estimated and then applying a 20% caloric restriction. In order to reduce body weight and maintain muscle mass, a high-protein diet will be provided consisting of 1.5 g of protein/kg/day.

Participants will be provided with a 3-day food record (3-DFR) chart prior to their baseline visit. After a full nutritional evaluation, the dietitian will create a diet plan unique to the participant. For those participants struggling to attain their recommended intake or anticipating protein intake to be challenging, an oral whey powder supplement will be provided for the duration of the study. Additional approaches to overcoming dietary challenges will include information/resources on nutritional symptom management that can impact dietary intake and/or high-protein recipes.

The exercise program will be based on supervised aerobic and resistance exercise home-based training sessions 3 times/week. The sessions will be 60 minutes long and will include 5 minutes of flexibility, followed by 25 minutes of aerobic exercises, 25 minutes of resistance exercises, and 5 minutes of balance exercises. The physiotherapist will supervise the sessions and will provide monthly individual face-to-face counselling to assure adherence to the protocol. The investigators have designed an individualized exercise program that fits the current patient's clinical situation. Each patient will receive a fitness tracker band to monitor his/her activity.

Behavioural support will include problem-solving strategies and practical tools to facilitate participants' self-control on emotional eating or stress-driven behaviours. Targeted behaviour goals will be set. A psychologist will provide technical support and training to the dietitian and the physiotherapist to improve their skills to provide behavioural changes and motivation.

Вмешательства

• Поведенческое Multimodal weight management program
  This intervention consists of three components: * Nutritional Counseling: * A personalized hypocaloric and high-protein diet is prescribed, based on individual energy requirements with a 20% caloric reduction. * The protein intake target is 1.5 g/kg/day to promote fat loss while maintaining muscle mass. * Exercise Program * Home-based, supervised aerobic and resistance training sessions conducted 3 times per week. * Each 60-minute session includes: 5 minutes flexibility, 25 minutes ae

Первичные конечные точки

• Accrual [Срок оценки: From baseline to end of cancer treatment (3 to 9 months)]
• Retention [Срок оценки: From baseline to end of cancer treatment (3 to 9 months)]
• Fidelity of the programme delivery [Срок оценки: From baseline to end of cancer treatment (3 to 9 months)]
• Nutritional adherence [Срок оценки: From baseline to end of cancer treatment (3 to 9 months)]
• Physical activity adherence [Срок оценки: From baseline to end of cancer treatment (3 to 9 months)]
• Ocurrance of any serious or life-threatening adverse events (Safety) [Срок оценки: Throughout the study period (from baseline to end of intervention, 3 to 9 months)]

Вторичные конечные точки (5)

• Change in Body Weight and Body Composition [Срок оценки: Baseline to end of treatment (approx. 3 to 9 months)]
• Change in Eating Self-Efficacy [Срок оценки: Baseline to the end of intervention (approx. 3 to 9 months)]
• Change in physical activity self-efficacy [Срок оценки: Baseline to the end of intervention (approx. 3 to 9 months)]
• Change in Autonomous Motivation [Срок оценки: Baseline to the end of intervention (approx. 3 to 9 months)]
• Modified Glasgow Prognostic Score [Срок оценки: Baseline and end of treatment (3 to 9 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• Institut Català d'Oncologia. Catalan Institute of Oncology — L'Hospitalet de Llobregat

Публикации

• Llenas-Blade A, Puig Figueras M, Padilla Padilla C, Esteve A, Zamora-Ros R, Daura I Vidal M, Ochoa-Arnedo C, Pernas S, Santos Vivas C, Brenes J, Jimenez-Colomo L, Asiain L, Nadal E, Arribas L. Weight management in obese cancer patients during curative active treatment: protocol for the CANOBESE feasibility study. Pilot Feasibility Stud. 2026 Jun 24. doi: 10.1186/s40814-026-01868-w. Online ahead of PMID 42343485

Идентификаторы

NCT: NCT07058207 · PR079/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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