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

NCT ID: NCT05573776

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-01-10

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.

Conditions

Gastric Cancer; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Therapy, High Protein supplement

Group Type: EXPERIMENTAL

Exercise Therapy, High Protein supplement

Intervention Type: OTHER

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.

Interventions

Exercise Therapy, High Protein supplement

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkyu Jung

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cancer Center, Yonsei University College of Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2020-0455

Identifier Type: -

Identifier Source: org_study_id