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NCT Number: NCT05356117

Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: 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

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Christina M Dieli-Conwright, PhD

PRINCIPAL_INVESTIGATOR

Christina M Dieli-Conwright, PhD, MPH

CONTACT

[email protected]

617-632-3800

PhD, MPH

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina M Dieli-Conwright, PhD, MPH

CONTACT

[email protected]

617-582-8321

Christina M Dieli-Conwright, PhD, MPH

CONTACT

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 2, 2022
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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