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Trial Title:
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
NCT ID:
NCT06565052
Condition:
Rectal Cancer
Colorectal Cancer
Rectal Cancer Stage II
Rectal Cancer Stage III
Conditions: Official terms:
Colorectal Neoplasms
Rectal Neoplasms
Conditions: Keywords:
Rectal Cancer
Colorectal Cancer
Rectal Cancer Stage II
Rectal Cancer Stage III
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Masking description:
Investigators blinded to block size
Intervention:
Intervention type:
Behavioral
Intervention name:
Prehabilitation Program
Description:
A hybrid-based, prehabilitation regimen comprised of nutritional optimization
(multivitamin and protein supplement shake) and virtual, aerobic and resistance exercise
sessions with clinical exercise physiologists. Virtual exercise sessions will be
performed via a HIPAA-compliant videoconferencing platform or by phone call.
Mini-exercise cycle ergometer, dumbbells, and resistance bands will be provided and
delivered to participant. Heart rate monitors and wi-fi enable tablet will be provided if
needed.
Arm group label:
Group A: Prehabilitation Program
Summary:
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
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Contact:
Last name:
Jeffrey Meyerhardt, MD, MPH
Phone:
617-632-6855
Email:
jeffrey_meyerhardt@dfci.harvard.edu
Investigator:
Last name:
Jeffrey Meyerhardt, MD
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Joel Goldberg, MD
Phone:
617-732-8460
Email:
JGOLDBERG1@PARTNERS.ORG
Investigator:
Last name:
Joel Goldberg, MD
Email:
Principal Investigator
Start date:
February 2025
Completion date:
August 7, 2027
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06565052
