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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05573776
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; Pancreatic Cancer	Other: Exercise Therapy, High Protein supplement	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Comparison of muscle mass between exercise therapy alone and high protein supplement combination groups [6weeks]

   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)

2. Comparison of muscle variation between exercise therapy alone and high protein supplement combination groups [6weeks]

   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)

Secondary Outcome Measures

1. Exercise Compliance [3years]

   As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%)

2. High Protein/Placebo Supplement rate [3years]

   As assessed by compliance for planned high protein/placebo supplementation rate (%)

3. Quality of Life (QoL) Evaluation (Korean version EORTC QLQ-C30) [3years]

   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.

4. Nutritional status assessment [3years]

   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)

5. Progression-free survival (PFS) [3years]

   Progression-free survival (PFS): To evaluate the treatment effect of High Protein/Placebo Supplement on progression-free survival (PFS) rate at 3years

6. Overall Survival (OS) [3years]

   Overall Survival (OS): The time from the date of first dose and the date of death from any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT05573776
• Other Study ID Numbers: 4-2020-0455
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 10, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Stomach Neoplasms

Study Results

No Results Posted as of Oct 10, 2022