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

Yonsei University

Status: Completed

Conditions: Gastric Cancer; Pancreatic Cancer

Treatments: Other: Exercise Therapy, High Protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05573776

4-2020-0455

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has provided signed written informed Consent
2. Has a histologically confirmed gastric or pancreatic cancer
3. 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

1. Age under 19 or over 90 year of age
2. Eastern Cooperative Oncology Group (ECOG) ≥ 2
3. Patients with severe malnutritional evaluation (PG-SGAC)
4. 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.
5. A person with previous uncontrolled seizures, central nervous system or psychological disorders
6. Have uncontrolled active infection or sepsis
7. Have deep vein thrombosis occurs within 4 weeks prior to the start of test recruitment
8. 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
9. Pregnant or lactating women. Pregnancy test results are positive in childbearing women
10. Gastrointestinal obstruction, malabsorption syndrome, or diseases that significantly affect digestive functions

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Exercise Therapy, High Protein supplement

Experimental group

Treatment:

Other: Exercise Therapy, High Protein supplement