Resistance exercise and protein supplementation for pancreatic cancer patients
Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial
This study is testing if a combination of resistance exercise and protein supplements can help pancreatic cancer patients starting chemotherapy improve their muscle mass, physical function, and overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05356117 on ClinicalTrials.gov |
What this trial studies
This research evaluates the feasibility of a virtually supervised resistance exercise program combined with protein supplementation for patients with pancreatic cancer starting chemotherapy. The study is a randomized controlled trial comparing three groups: those receiving both resistance exercise and protein supplementation, those receiving only resistance exercise, and an attention control group focused on home-based stretching. The primary goal is to assess improvements in skeletal muscle mass, biomarkers of tissue wasting, physical function, and overall quality of life over a period of four months. Participants will undergo extensive evaluations including fitness assessments and blood tests throughout the study.
Who should consider this trial
Good fit: Ideal candidates are non-metastatic pancreatic cancer patients who are starting neoadjuvant chemotherapy and are able to participate in a supervised exercise program.
Not a fit: Patients with uncontrolled illnesses or those unable to engage in moderate physical activity due to cardiovascular, respiratory, or musculoskeletal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help improve muscle mass and overall quality of life for patients undergoing chemotherapy for pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with exercise interventions in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina M Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina M Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.