Weight Management in Obese Cancer Patients During Curative Active Treatment

NCT07058207 | Recruiting

• 1 other identifier: PR079/25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Solid Neoplasm; Stage II-IV; Curative Treatment

Keywords

Obesity; Neoplasms; Antineoplasic agents; Chemotherapy; Radiotherapy; Weight Loss; Physical Activity; Feasibility Studies; Patient Compliance; Patient Motivation; Patient Adherence; Patient Dropouts; Treatment-related adverse effects; Biomarkers; nutritional intervention; curative-intent treatment

Outcome Measures

Primary Outcomes (6)

• Accrual

  Feasibility will be evaluated based on participant accrual, measured by the weekly enrollment rate and the total duration required to achieve the target sample size.

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

• Retention

  Feasibility will be assessed based on participant retention, monitored through attendance records signed at each visit. Investigators will calculate the retention rate, dropout rate, time to dropout, and reasons for discontinuation.

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

• Fidelity of the programme delivery

  Feasibility based on fidelity of the intervention will be assessed using a patient-completed checklist after each dietetic and physiotherapy session. Items will be scored as: +1: session content delivered as intended, 0: content omitted, -1: content delivered in a way that deviates from protocol. Fidelity scores will be aggregated, and if overall fidelity drops below 80%, retraining may be considered. Additionally, patients will complete a final evaluation form at the end of the program assessing intervention load, frequency, delivery format, behavioral support, and perceived value (e.g., effort, satisfaction, willingness to repeat).

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

• Nutritional adherence

  Feasibility based on adherence will be evaluated using a 24-hour dietary recall to assess energy and protein intake. At the end of the intervention period, dietary adherence will also be defined as a 10-20% reduction in baseline calorie intake, along with maintenance or an increase in protein intake.

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

• Physical activity adherence

  Feasibility based on physical activity adherence will be assessed through physiotherapist evaluations and wearable device tracking.

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

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

  Safety will be evaluated by monitoring the occurrence of any serious or life-threatening adverse events that may be attributable to the intervention. Specifically, investigators will record physical or cardiac events resulting in overnight hospitalization. The clinical team will assess and document whether each event is related to the dietary, exercise, or behavioral components of the intervention.

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

Secondary Outcomes (5)

• Change in Body Weight and Body Composition

  Baseline to end of treatment (approx. 3 to 9 months)

• Change in Eating Self-Efficacy

  Baseline to the end of intervention (approx. 3 to 9 months)

• Change in physical activity self-efficacy

  Baseline to the end of intervention (approx. 3 to 9 months)

• Change in Autonomous Motivation

  Baseline to the end of intervention (approx. 3 to 9 months)

• Modified Glasgow Prognostic Score

  Baseline and end of treatment (3 to 9 months)

Study Arms (1)

Cancer patients with obesity with active curative treatment

EXPERIMENTAL

Fifty adult cancer patients with obesity (BMI ≥30 kg/m²) newly diagnosed with stage II-IV solid tumors undergoing curative-intent treatment. Participants will receive a multimodal weight management program combining dietary intervention, physicial activity and behavioral support.

Behavioral: Multimodal weight management program

Interventions

Multimodal weight management program BEHAVIORAL

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 aerobic training, 25 minutes resistance training, and 5 minutes balance exercises. * Behavioral Support * Patients receive training in problem-solving strategies, motivation, and emotional self-regulation to improve adherence to both dietary and exercise goals. * Health professionals delivering the intervention are trained in behavior change techniques by a clinical psychologist.

Cancer patients with obesity with active curative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• World Cancer Research Fund International: collaborator
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Institut Català d'Oncologia. Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Neoplasms; Weight Loss; Motor Activity; Patient Compliance; Patient Dropouts

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Lorena Arribas, PhD, MsC, RD

  Catalan Institute of Oncology (ICO-Hospitalet). Bellvitge Biomedical Research Institute (IDIBELL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Arribas

CONTACT

+34932607751; larribas@iconcologia.net

Marta Puig

CONTACT

+34932607751; mpuig@iconcologia.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-arm intervention study designed to assess feasibility, accrual rate, retention, compliance and safety of a multimodal weight management program in obese cancer patients undergoing curative treatment.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 10, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)