Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up.

NCT06323733 | Enrolling By Invitation

• 1 other identifier: 2CAPA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms. Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention.

Conditions

Cachexia-Anorexia Syndrome

Keywords

Cachexia; Cancer; Exercise; Body composition; Quality of life

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  Health-Related Quality of Life: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) version 3.0 will be used to assess changes in levels of health-related Quality of Life (QOL). The EORTC QLQ-C30 is an internationally validated, concise, self-reporting cancer-specific measure of health-related QOL (25). This scale comprises 30 items, including one global health status/QOL scale and five multi-item functional scales evaluating physical, role, emotional, cognitive, and social function. Additionally, three multi-item symptom scales assess fatigue, pain, and nausea/vomiting, and six single items assess symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. A high score for the global health status and QoL and for the functional scales represents a high level of QoL and functioning. Nevertheless, a high score for a symptom scale / item represents a high level of symptomatology.

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

Secondary Outcomes (13)

• Body weight

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

• Body mass index

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

• Lean mass

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

• Fat mass

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

• Aerobic fitness

  Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks

Other Outcomes (7)

• Compliance to exercise intervention

  During the 12-week program

• Reasons for absence

  During the 12-week program

• Timing of absences

  During the 12-week program

Study Arms (1)

Exercise intervention

EXPERIMENTAL

The exercise intervention will consist of a personalized and supervised program lasting 12 weeks with two sessions per week, held on Tuesdays and Thursdays at the Sports and Medicine Center SPORMED in Rennes, France. Each session will combine endurance and resistance training, commencing with a 6-minute cardiovascular warm-up on ergometers (cycling ergometer or treadmill). This will be followed by 20 minutes at moderate intensity (60-70% of Heart Rate Reserve (HRR)), concluding with a 2-minute recovery period at light intensity. Heart rate will be monitored using a pulse oximeter. Participants will report their rate of perceived exertion during endurance training using a 5-point scale ("very easy," "easy," "moderate," "difficult," "very difficult").

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

The exercise intervention will consist of a personalized and supervised program lasting 12 weeks with two sessions per week, held on Tuesdays and Thursdays at the Sports and Medicine Center SPORMED in Rennes, France. Each session will last 1 hour under the supervision of physiotherapists. Each session will combine endurance and resistance training, commencing with a 6-minute cardiovascular warm-up on ergometers (cycling ergometer or treadmill). This will be followed by 20 minutes at moderate intensity (60-70% of

Exercise intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Diagnosis of cancer cachexia according to Martin's classification
• Undergoing treatment or within 1 year post-treatment (of any type), with or without metastasis
• Eastern Cooperative Oncology Group Performance status ≤ 2, 5) life expectancy ≥ 3 months
• Willingness to actively participate throughout the study
• Ability to engage in supervised exercise program as certified by their oncologist
• Valid health insurance affiliation,
• Proficiency in reading, writing, and understanding French.

You may not qualify if:

• Exhibit central nervous system involvement with neurological deficits restricting walking
• Are concurrently participating in another exercise intervention study,
• Are pregnant
• Are under legal or administrative detention/ deprived of liberty by judicial or administrative decision.

Sponsors & Collaborators

• Peyrachon Romane: lead

Study Sites (1)

SPORMED

Rennes, Brittany Region, 35000, France

Location

Related Publications (1)

• Peyrachon R, Richard C, Gelein B, Lievre A, Andre N, Chaory K, Rebillard A. Rationale and design of an exercise intervention for patients with cancer cachexia: protocol for a one-year follow-up prospective study (2CAPA). BMC Sports Sci Med Rehabil. 2025 May 24;17(1):129. doi: 10.1186/s13102-025-01173-8.

  PMID: 40413464 DERIVED

MeSH Terms

Conditions

Cachexia; Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Behavior

Study Officials

• Romane Peyrachon, MhD

  Rennes 2 University, M2S lab EA7470

  PRINCIPAL INVESTIGATOR

• Amélie Rébillard, PhD

  Rennes 2 University, M2S lab EA7470

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator, PhD

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 21, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Information will be available in 2024 for an infinite duration.
• Access Criteria: Open access

Locations

FR (1)