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NCT Number: NCT05573776

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: 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 outcomes

  1. Exercise Compliance

    Time frame: 3years

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

  2. High Protein/Placebo Supplement rate

    Time frame: 3years

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

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 3years

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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