- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356117
Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial
The purpose of this research is to determine whether a virtually supervised resistance exercise (RE) intervention combined with protein supplementation (PS) is feasible in pancreatic cancer patients initiating chemotherapy and if it will improve skeletal muscle mass.
The names of the study interventions involved in this study are:
- Resistance training and protein supplement intake (RE + PS)
- Resistance training (RE)
- Attention control (AC), home-based stretching
Study Overview
Status
Conditions
Detailed Description
This research study is a randomized controlled trial that will assess feasibility and compare skeletal muscle mass, biomarkers of tissue wasting, physical function, and overall quality of life between three groups - exercise and supplement, exercise-only, and attention control. This study intends to evaluate whether resistance exercise and protein supplementation can improve skeletal muscle mass as well as decrease tissue wasting biomarkers in the blood, among patients undergoing chemotherapy for pancreatic cancer as there is some evidence that pancreatic cancer patients can experience muscle wasting while on chemotherapy.
The research study procedures include: screening for eligibility and study treatment including extensive evaluations of participant fitness and body composition including CT, blood tests, fitness and strength assessments, and surveys at study entry, half-way through the intervention, and follow-up visit.
Participants in this study will be randomly assigned to one of three groups: 1) Resistance exercise and protein supplementation (RE+ PS), 2) Resistance exercise (RE), or 3) Attention control (AC).
This research study is expected to last for up to a total of 4 months.
It is expected that about 45 people will take part in this research study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina M Dieli-Conwright, PhD, MPH
- Phone Number: 617-582-8321
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
Study Contact Backup
- Name: Christina M Dieli-Conwright, PhD, MPH
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
Contact:
- Christina M Dieli-Conwright, PhD, MPH
- Phone Number: 617-632-3800
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
-
Contact:
- PhD, MPH
-
Principal Investigator:
- Christina M Dieli-Conwright, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Non-metastatic pancreatic cancer patients initiating neoadjuvant chemotherapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease.
- Speak English or Spanish.
- Able to provide physician clearance to participate in the exercise program.
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity).
- Currently participate in less than or equal to 60 minutes of structured moderate or vigorous exercise/week.
- Does not smoke (no smoking during previous 12 months).
- Willing to travel to DFCI for assessments.
Exclusion Criteria:
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease.
- Patients may not be receiving any other investigational agents.
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease.
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise.
- Patients expected to receive other cancer directed treatments during the study and assessment period.
- Participates in more than 60 minutes of structured moderate or vigorous exercise/week.
- Currently smokes.
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Is unable to travel to DFCI for assessments.
- Patients who are pregnant due to the unknown effects of exercise on the developing fetus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance Training (RT) and Protein Supplementation (PS)
Participants will be randomly assigned to the Resistance Training (RT) and Protein Supplementation (PS) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week with daily protein supplementation for the duration of their chemotherapy with a maximum of 16-weeks of exercise. Exercises will be tailored to the participants' fitness levels. Sessions will last ~60 minutes including 5-minute warm-up and 5-minute cool-down. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions. |
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
|
Experimental: Resistance Training (RT)
Participants will be randomly assigned to the Resistance Training (RT) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week. Exercises will be tailored to the participants' fitness levels. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions. |
Aerobic and resistance exercise
|
Active Comparator: Attention Control (AC)
Participants will be randomly assigned to the Attention Control (AC) group and receive instruction on a home-based, 3 days a week stretching program. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions. The attention control group will be given the option to participate in the exercise intervention after their treatment is completed, with a cap of a 16-week period. |
Stretching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Session Attendance Rate
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
The primary outcome is feasibility.
Feasibility of the resistance exercise (RE) +protein supplementation (PS) intervention will be defined as the proportion of exercise sessions attended and consumption of the PS.
The intervention is considered feasible if the proportion of enrolled participants who complete the exercise sessions and daily PS is ≥70%, respectively.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Protein Supplementation (PS) Rate
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
The primary outcome is feasibility.
Feasibility of the resistance exercise (RE) +protein supplementation (PS) intervention will be defined as the proportion of exercise sessions attended and consumption of the PS.
The intervention is considered feasible if the proportion of enrolled participants who complete the exercise sessions and daily PS is ≥70%, respectively.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal Muscle Mass Change
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Skeletal muscle mass will be assessed by standardized body composition analysis of clinical CT scans.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Tissue Wasting Biomarker Change
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Plasma biomarkers will be analyzed for IL-6, MCP-1, TNF-RII, and branched chain amino acids.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical function - Margaria Stair Climb
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Functional power will be measured using the Margaria Stair Climb test.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Muscular Strength
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Muscular strength will be assessed with a 10 repetition maximum test.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Fitness - Performance
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Fitness will be measured by the short physical performance battery (SPPB).
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Fitness - Sit to Stand
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Fitness will be measured by the sit to stand test.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Gait Speed
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Gait Speed will be measured by a short walk over a 6-meter flat distance at usual and fast speeds.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Function - Handgrip Strength
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Handgrip strength will be measured by a hand-held dynamometer.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Function - 6 minute walk test
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical function will be assessed with the 6 minute walk test (6MWT).
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Fatigue
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Fatigue will be measured by the Brief Fatigue Inventory (BFI).
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Quality of Life
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Quality of life will be assessed by the functional assessment of cancer therapy - Hepatobiliary (FACT-Hep).
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Depression
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Depression will be assessed by the Center for Epidemiologic Studies Depression scale.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Sleep
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Sleep will be assessed by the Pittsburg sleep quality index (PSQI).
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Pain
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Pain will be assessed by the Brief Pain Inventory.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Barriers to Recruitment
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Barriers will be assessed by the Barriers to Recruitment Participation Questionnaire.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Benefits and Barriers
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Benefits & Barriers will be assessed by the Exercise Benefits/Barriers Scale Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Burden
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Burden will be assessed by the Perceived Research Burden Assessment.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Anxiety
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Anxiety will be assessed by the The State-Trait Anxiety Inventor.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Psychosocial function - Physical Function
Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Physical Function will be assessed by the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.
Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test.
For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
|
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina M Dieli-Conwright, PhD, MPH, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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