This clinical trial evaluates whether a hybrid-based prehabilitation program can improve outcomes after surgery for patients with stage II-III rectal cancer undergoing chemotherapy and/or radiation before surgery (neoadjuvant). Patients diagnosed with rectal cancer undergo a variety of types of treatment, including chemotherapy, radiation therapy, and surgery, and most patients will undergo a combination of them. These are all intensive treatment types which may have adverse side effects that negatively impact patients' outcomes and quality of life. Recent research has shown that prehabilitation, or the practice of improving one’s physical reserve through improvements in diet and exercise prior to undergoing these treatments, can potentially help improve these outcomes and enhance the recovery process. Specifically, for patients with colorectal cancer who undergo surgery, prehabilitation has shown promising results in reducing adverse outcomes afterwards. Information gathered from this study may help researchers determine whether participating in hybrid-based prehabilitation program may be used for improving outcomes for patients with stage II-III rectal cancer undergoing treatment chemotherapy and/or radiation before surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT06565052.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Jeffrey A. Meyerhardt
Phone: 617-632-6855
Dana-Farber Cancer InstituteStatus: Active
Contact: Jeffrey A. Meyerhardt
Phone: 617-632-6855
PRIMARY OBJECTIVE:
I. To determine the feasibility and safety of implementation of a non-blinded randomized control trial comparing a prehabilitation exercise program and a control group for patients with rectal cancer who have completed neoadjuvant treatment and are expected to potentially undergo surgical resection or be followed with nonoperative management.
SECONDARY OBJECTIVE:
I. To investigate if a prehabilitation exercise program can improve functional capacity, health outcomes, and result in higher quality of life when compared to a control group that does not receive the prehabilitation intervention among patients with rectal cancer.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients participate in an in-person and virtually-based supervised aerobic, resistance training, and stretching program with provided equipment over 60-70 minutes three times a week (TIW) before surgery or non-surgical management surveillance. Patients may also receive nutritional support and multivitamin orally (PO) daily for 4 weeks before surgery or non-surgical management surveillance. Patients also undergo blood sample collection throughout the study.
GROUP B: Patients maintain baseline exercise behavior and/or usual, daily activities before surgery or non-surgical management surveillance. Patients are offered the same exercise equipment and nutritional support that was provided to the prehabilitation group along with a booklet on how to perform the exercises following the initial 4-week study period. Patients also undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJeffrey A. Meyerhardt
