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

NCT05573776 | Completed DMC

• 1 other identifier: 4-2020-0455
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Exercise Compliance

  3years

• High Protein/Placebo Supplement rate

  3years

• Quality of Life (QoL) Evaluation (Korean version EORTC QLQ-C30)

  3years

• Nutritional status assessment

  3years

• Progression-free survival (PFS)

  3years

Study Arms (1)

Exercise Therapy, High Protein supplement

EXPERIMENTAL

Other: Exercise Therapy, High Protein supplement

Interventions

Exercise Therapy, High Protein supplement 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.

Exercise Therapy, High Protein supplement

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided signed written informed Consent
• Has a histologically confirmed gastric or pancreatic cancer
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Minkyu Jung

  Yonsei Cancer Center, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 10, 2022
• Study Start: August 1, 2020
• Primary Completion: December 22, 2022
• Study Completion: January 10, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)