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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573776
• Other study ID #: 4-2020-0455
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: May 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 10, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Exercise Compliance	As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%)	3years
Secondary	High Protein/Placebo Supplement rate	As assessed by compliance for planned high protein/placebo supplementation rate (%)	3years
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	Overall Survival (OS): The time from the date of first dose and the date of death from any cause.	3years