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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05356117
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Resistance Training (RT) and Protein Supplementation (PS) — BEHAVIORAL
    Aerobic and resistance exercise with orally consumed pre-packed protein supplement
  • Resistance Training (RT) — BEHAVIORAL
    Aerobic and resistance exercise
  • Attention Control (AC — BEHAVIORAL
    Stretching

Study Details

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

Key Dates

Start date
Sep 1, 2022
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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.

Primary Outcome Measure

Exercise Session Attendance Rate [ Time Frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) ]

Central Contacts

  • Christina M Dieli-Conwright, PhD, MPH
    617-582-8321
    [email protected]
  • Christina M Dieli-Conwright, PhD, MPH

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Christina M Dieli-Conwright, PhD, MPH
[email protected]
617-632-3800
PhD, MPH
Christina M Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Dana Farber Cancer Institute· Boston, MA

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