Trial Summary
What is the purpose of this trial?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
Eligibility Criteria
This trial is for individuals with rectal cancer who are about to start neoadjuvant chemotherapy and/or radiation, followed by surgery. Specific eligibility details are not provided, but typically participants must meet certain health standards.Inclusion Criteria
I understand the study and agree to participate.
My condition is stage II-III rectal cancer.
English-Speaking
+2 more
Exclusion Criteria
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
Comorbid conditions or cognitive/physical impairments that contraindicate exercise
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Prehabilitation
Participants in Group A undergo a prehabilitation program with virtual exercise sessions 3 days per week for 4 weeks, along with IMN supplementation and daily multivitamin.
4 weeks
Virtual exercise sessions 3 times per week
Neoadjuvant Therapy
Participants receive neoadjuvant chemotherapy and/or radiation before surgical resection.
Varies
Surgery
Participants undergo resection surgery per standard of care.
1 day
In-clinic visit for surgery
Postoperative Follow-up
Participants have an in-clinic 30-day postoperative visit to assess recovery and outcomes.
4 weeks
In-clinic visit at 30 days post-surgery
Participant Groups
The PROPEL Trial is testing the effectiveness of a prehabilitation program (Group A) compared to usual care (Group B) in improving outcomes for patients undergoing treatment for rectal cancer.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A: Prehabilitation ProgramExperimental Treatment1 Intervention
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.
Group II: Group B: Usual CareActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Dana-Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor