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Completed
NCT06737692
Effects of Aerobic and Resistance Exercise Training in Individuals With Cancer Cachexia
Conditions: Cancer Cachexia (CC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Dokuz Eylul University
Location: Dokuz Eylül University Izmir
Summary
This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.
A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.
Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:
Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.
The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.
The intensity will be progressively adjusted based on the individual's perceived exertion.
Eligibility Criteria
Inclusion Criteria:
* Stage III-IV gastrointestinal cancer diagnosis
* Age ≥ 18 years
* Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery,
* Karnofsky performance score 80 and above,
* Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (\>5% weight loss in the last 6 months or \>2% weight loss in patients with BMI less than 20 kg/m2 or \>2% weight loss in sarcopenic individuals)
Exclusion Criteria:
* Musculoskeletal disorder
* Neurological disorder
* Severely impaired hematological capacity
* History of cardiac disease
* Uncontrolled hypertension
* Severe renal insufficiency
* Advanced osteoporosis
* Decreased ability to stand or walk
Source: ClinicalTrials.gov (NCT06737692). StuddyBuddy aggregates publicly available trial information.