Recruiting

Resistance Exercise with Protein SupplementationResistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05356117

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resistance Training (RT) and Protein Supplementation (PS)

Resistance Training (RT)

Attention Control (AC

Study Details

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

Conditions

Pancreatic Cancer

Study ID

NCT05356117

Start date

Sep 1, 2022

Status verified date

Feb, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Resistance Training (RT) and Protein Supplementation (PS)

Aerobic and resistance exercise with orally consumed pre-packed protein supplement

Resistance Training (RT)

Aerobic and resistance exercise

Attention Control (AC

Stretching

Primary outcome measure

Exercise Session Attendance Rate [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Christina M Dieli-Conwright, PhD, MPH

617-582-8321 ChristinaM_Dieli-Conwright@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina M Dieli-Conwright, PhD, MPH

617-632-3800 ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina M Dieli-Conwright, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

Pancreatic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-19.