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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Other: Exercise Therapy, High Protein supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Therapy, High Protein supplement<br> | Other: Exercise Therapy, High Protein supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of muscle mass between exercise therapy alone and high protein supplement combination groups | 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) | 6weeks | 
| Comparison of muscle variation between exercise therapy alone and high protein supplement combination groups | 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) | 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Compliance | As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%) | 3years | 
| High Protein/Placebo Supplement rate | As assessed by compliance for planned high protein/placebo supplementation rate (%) | 3years | 
| Quality of Life (QoL) Evaluation (Korean version EORTC QLQ-C30) | European Organization for Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) Korean version EORTC QLQ-C30 consists of 30 questions, and total score will be reported. Response options for each EPIC question form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale. The higher the score, the higher the quality of life. Using the QOL questionnaire (EOGRTC QLQ-C30), a total of 3 measurements were taken before chemotherapy and 1 week after chemotherapy. | 3years | 
| Nutritional status assessment | Nutritional status assessment for the exercise therapy single group versus the high-protein supplement combination group as assessed by PG-SGA(the Scored Patient-Generated Subjective Global Assessment) | 3years | 
| Progression-free survival (PFS) | Progression-free survival (PFS): To evaluate the treatment effect of High Protein/Placebo Supplement on progression-free survival (PFS) rate at 3years | 3years | 
| Overall Survival (OS) | Overall Survival (OS): The time from the date of first dose and the date of death from any cause. | 3years |