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

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

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Pancreatic Cancer
• Intervention / Treatment: Other: Exercise Therapy, High Protein supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Therapy, High Protein supplement	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Minkyu Jung, Yonsei Cancer Center, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Stomach Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: 4-2020-0455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No