Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Sep 2022
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2027
February 19, 2026
February 1, 2026
4.4 years
April 15, 2022
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exercise Session Attendance Rate
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
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 Outcomes (19)
Skeletal Muscle Mass Change
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Tissue Wasting Biomarker Change
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical function - Margaria Stair Climb
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Muscular Strength
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical Fitness - Performance
Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
- +14 more secondary outcomes
Study Arms (3)
Resistance Training (RT) and Protein Supplementation (PS)
EXPERIMENTALParticipants 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.
Resistance Training (RT)
EXPERIMENTALParticipants 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.
Attention Control (AC)
ACTIVE COMPARATORParticipants 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.
Interventions
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina M Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Christina M Dieli-Conwright, PhD, MPH
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 15, 2022
First Posted
May 2, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
August 15, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.