A Pilot Study of the Effect of High Protein Supplement and Exercise Therapy on Preservation of Skeletal Muscle Mass and Quality of Life in Patients With Gastric Cancer and Pancreatic Cancer Treated With Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Comparison of muscle variation between exercise therapy alone and high protein supplement combination groups
Study Overview
Brief Summary
For gastric and pancreatic cancer patients scheduled for primary chemotherapy, we would like to report muscle mass preservation and improvement in quality of life in Chinese characters that received only exercise therapy and high protein supplements at the same time
Detailed Description
Sixty patients with gastric and pancreatic cancer will be eligible, and 30 patients will be randomly assigned to the exercise therapy + high protein supplement group and 30 patients to the exercise therapy + placebo supplement group.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has provided signed written informed Consent
- •Has a histologically confirmed gastric or pancreatic cancer
- •Has a patient scheduled for chemotherapy - Patients who are scheduled to be treated with TS-1 or Xelox for gastric cancer-adjuvant chemotherapy - Patients scheduled for primary chemotherapy for pancreatic cancer-progressive/transitional diseases
Exclusion Criteria
- •Age under 19 or over 90 year of age
- •Eastern Cooperative Oncology Group (ECOG) ≥ 2
- •Patients with severe malnutritional evaluation (PG-SGAC)
- •Any of the following within 3 months prior to study recruitment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
- •A person with previous uncontrolled seizures, central nervous system or psychological disorders
- •Have uncontrolled active infection or sepsis
- •Have deep vein thrombosis occurs within 4 weeks prior to the start of test recruitment
- •Severe acute or chronic conditions that may reduce the patient's ability to participate in clinical trials or make it difficult to interpret clinical trial results
- •Pregnant or lactating women. Pregnancy test results are positive in childbearing women
- •Gastrointestinal obstruction, malabsorption syndrome, or diseases that significantly affect digestive functions
Arms & Interventions
Exercise Therapy, High Protein supplement
Intervention: Exercise Therapy, High Protein supplement (Other)
Outcomes
Primary Outcomes
Comparison of muscle variation between exercise therapy alone and high protein supplement combination groups
Time Frame: 6weeks
Comparison of muscle variation between the exercise therapy single group and the high-protein supplement combination group as assessed by Bioelectrical impedance analsis (BIA) (performed in Week 6)
Comparison of muscle mass between exercise therapy alone and high protein supplement combination groups
Time Frame: 6weeks
Comparison of muscle mass between the exercise therapy single group and the high-protein supplement combination group as assessed by Bioelectrical impedance analsis (BIA) (performed in Week 6)
Secondary Outcomes
- Exercise Compliance(3years)
- High Protein/Placebo Supplement rate(3years)
- Progression-free survival (PFS)(3years)
- Overall Survival (OS)(3years)
- Quality of Life (QoL) Evaluation (Korean version EORTC QLQ-C30)(3years)
- Nutritional status assessment(3years)