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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
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.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
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)
Time frame: 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)
Time frame: 6weeks
Exercise Compliance
As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%)
Time frame: 3years
High Protein/Placebo Supplement rate
As assessed by compliance for planned high protein/placebo supplementation rate (%)
Time frame: 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.
Time frame: 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)
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Time frame: 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
Time frame: 3years
Overall Survival (OS)
Overall Survival (OS): The time from the date of first dose and the date of death from any cause.
Time frame: 3years