NCT05356117 Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
| NCT ID | NCT05356117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2022-09-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Christina M Dieli-Conwright, PhD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05356117 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05356117 currently recruiting?
Yes, NCT05356117 is actively recruiting participants. Contact the research team at ChristinaM_Dieli-Conwright@dfci.harvard.edu for enrollment information.
Where is the NCT05356117 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05356117 clinical trial?
NCT05356117 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina M Dieli-Conwright, PhD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 45 participants.
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