The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial
Purpose
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: - Group A: Prehabilitation program - Group B: Usual Care
Conditions
- Rectal Cancer
- Colorectal Cancer
- Rectal Cancer Stage II
- Rectal Cancer Stage III
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age greater than or equal to 18 years at time of enrollment. - English-Speaking. - Diagnosis of clinical stage II-III rectal cancer. - Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow. - Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
Exclusion Criteria
- Distant metastatic disease known at the time of diagnosis. - Functional incapacity (i.e., incapable of performing exercise testing). - Comorbid conditions or cognitive/physical impairments that contraindicate exercise. - Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer. - Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial. - Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
- Masking Description
- Investigators blinded to block size
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group A: Prehabilitation Program |
Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: - In-clinic baseline visit with assessments - Virtual exercise sessions 3 days per week for 4 weeks. - IMN supplementation and daily multivitamin starting at 4 weeks of the preoperative phase. - Resection surgery per standard of care - In-clinic 30 day postoperative visit. |
|
|
No Intervention Group B: Usual Care |
Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: - In-clinic baseline visit with assessments - Resection surgery per standard of care - In-clinic 30 day postoperative visit - After completion of the study period, participants will be offered exercise equipment with an exercise instruction booklet. |
|
Recruiting Locations
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
Detailed Description
This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery. Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance. The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires. It is expected that about 40 participants will take part in this research study.