- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2020-08-01
2022-12-22
2023-01-10
80
NCT05573776
Yonsei University
Yonsei University
INTERVENTIONAL
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
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-09-26 | N/A | 2024-05-06 |
2022-10-07 | N/A | 2024-05-08 |
2022-10-10 | N/A | 2024-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Exercise Therapy, High Protein supplement | OTHER: Exercise Therapy, High Protein supplement
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
