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Pancreatic CancerNCT05356117

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

A study testing Resistance Training (RT) and Protein Supplementation (PS) and Resistance Training (RT) in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Resistance Training (RT) and Protein Supplementation (PS) and Resistance Training (RT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to 15 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christina M Dieli-Conwright, PhD, MPH contact

617-582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

Christina M Dieli-Conwright, PhD, MPH contact

United States1 site, 1 recruiting
  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Christina M Dieli-Conwright, PhD, MPH, 617-632-3800, ChristinaM_Dieli-Conwright@dfci.harvard.edu

    PhD, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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
Read the 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.

Being tested
Resistance Training (RT) and Protein Supplementation (PS), Resistance Training (RT), Attention Control (AC
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Training (RT) and Protein Supplementation (PS)Behavioural

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

  • Resistance Training (RT)Behavioural

    Aerobic and resistance exercise

  • Attention Control (ACBehavioural

    Stretching

Study groups in NCT05356117
Study groupRoleWhat they receive
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.
Receives: Behavioral: Resistance Training (RT) and Protein Supplementation (PS)
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.
Receives: Behavioral: Resistance Training (RT)
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.
Receives: Behavioral: Attention Control (AC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  2. 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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

Secondary outcomes (19)
  1. Skeletal Muscle Mass Change

    Skeletal muscle mass will be assessed by standardized body composition analysis of clinical CT scans.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  2. Tissue Wasting Biomarker Change

    Plasma biomarkers will be analyzed for IL-6, MCP-1, TNF-RII, and branched chain amino acids.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  3. Physical function - Margaria Stair Climb

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  4. Muscular Strength

    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

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  5. Physical Fitness - Performance

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  6. Physical Fitness - Sit to Stand

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  7. Gait Speed

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  8. Physical Function - Handgrip Strength

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  9. Physical Function - 6 minute walk test

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  10. Psychosocial function - Fatigue

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  11. Psychosocial function - Quality of Life

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  12. Psychosocial function - Depression

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  13. Psychosocial function - Sleep

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  14. Psychosocial function - Pain

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  15. Psychosocial function - Barriers to Recruitment

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  16. Psychosocial function - Benefits and Barriers

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  17. Psychosocial function - Burden

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  18. Psychosocial function - Anxiety

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

  19. Psychosocial function - Physical Function

    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.

    Measured: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05356117
Sponsor's protocol ID
21-506
Status last verified
Feb 2026
First submitted
15 Apr 2022
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Training (RT) and Protein Supplementation (PS) and Resistance Training (RT) in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christina M Dieli-Conwright, PhD, MPH (617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Session Attendance Rate (time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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