Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
Recruiting · NCT05356117 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Attention Control (ACResistance Training (RT)Resistance Training (RT) and Protein Supplementation (PS)
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States