protocolSection identificationModule nctId: NCT06323733, orgStudyIdInfo id: 2CAPA, briefTitle: Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up., acronym: 2CAPA, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Peyrachon Romane, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cachexia-Anorexia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Intervention, outcomesModule primaryOutcomes measure: Health-Related Quality of Life, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Lean mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Aerobic fitness, secondaryOutcomes measure: Muscular strength of the lower limbs, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Static balance ability, secondaryOutcomes measure: Appetite, secondaryOutcomes measure: Cancer-related Fatigue, secondaryOutcomes measure: Physical Activity and Sedentary Levels, secondaryOutcomes measure: Stages of change for exercise, secondaryOutcomes measure: Exercise beliefs, otherOutcomes measure: Compliance to exercise intervention, otherOutcomes measure: Reasons for absence, otherOutcomes measure: Timing of absences, otherOutcomes measure: Fidelity to session duration, otherOutcomes measure: Fidelity to session intensity, otherOutcomes measure: Reasons to modify exercise sessions, otherOutcomes measure: Incidence of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SPORMED, city: Rennes, state: Bretagne, zip: 35000, country: France, geoPoint lat: 48.11198, lon: -1.67429, hasResults: False