Back to resultsA 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
Primary Purpose
Gastric Cancer, Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Exercise Therapy, High Protein supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer
Eligibility Criteria
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
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise Therapy, High Protein supplement
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Exercise Compliance
As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%)
High Protein/Placebo Supplement rate
As assessed by compliance for planned high protein/placebo supplementation rate (%)
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.
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)
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
Overall Survival (OS)
Overall Survival (OS): The time from the date of first dose and the date of death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05573776
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Pancreatic Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Therapy, High Protein supplement
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise Therapy, High Protein supplement
Intervention Description
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 Outcome Measure Information:
Title
Comparison of muscle mass between exercise therapy alone and high protein supplement combination groups
Description
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)
Time Frame
6weeks
Title
Comparison of muscle variation between exercise therapy alone and high protein supplement combination groups
Description
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)
Time Frame
6weeks
Secondary Outcome Measure Information:
Title
Exercise Compliance
Description
As assessed by compliance for planned exercise (aerobic/strength exercise) adherence rate (%)
Time Frame
3years
Title
High Protein/Placebo Supplement rate
Description
As assessed by compliance for planned high protein/placebo supplementation rate (%)
Time Frame
3years
Title
Quality of Life (QoL) Evaluation (Korean version EORTC QLQ-C30)
Description
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.
Time Frame
3years
Title
Nutritional status assessment
Description
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)
Time Frame
3years
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS): To evaluate the treatment effect of High Protein/Placebo Supplement on progression-free survival (PFS) rate at 3years
Time Frame
3years
Title
Overall Survival (OS)
Description
Overall Survival (OS): The time from the date of first dose and the date of death from any cause.
Time Frame
3years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minkyu Jung
Phone
82-2-2228-8129
Email
minkjung@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minkyu Jung
Organizational Affiliation
Yonsei Cancer Center, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minkyu Jung
Phone
82-2-2228-8129
Email
minkjung@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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