Title: Physical Activity In Gastrointestinal Cancer (ClinicalTrials.gov Identifier: NCT03331406)
Principle Investigator: Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute, Boston, Massachusetts
Description: Researchers from the Dana-Farber Cancer Institute are seeking to evaluate the ability of patients with gastrointestinal cancer to participate in a physical activity program. The 12-week program includes moderate-intensity aerobic, strength, flexibility, and balance training. The aerobic training includes 150 weekly minutes of brisk walking and the goal of the strength, flexibility, and balance training are to engage in these activities 2 times each week.
The primary outcome measures for the trial include rate of accrual; the researchers are looking to recruit 20 patients within 12 months. The researchers are also seeking to demonstrate that at least half of the participants adhered to at least 50% of the prescribed physical activity program. Secondary outcome measures include rate of retention, the number of patients that complete assessment procedures, and adverse events.
In order to enroll, patients must have a diagnosis of histologically confirmed esophageal, gastric, pancreatic, or colorectal cancer that is metastatic or locally advanced and they must have received first-line cytotoxic chemotherapy started within 4 weeks of enrollment. Patients must also be older than 65 years.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03331406.
Status: The trial is open and recruiting patients as of December 1, 2017. The estimated enrollment for the trial is 20 participants.
- Clinicaltrials.gov. Physical activity in gastrointestinal aancer. NCT03331406. https://clinicaltrials.gov/ct2/show/ NCT03331406. Accessed December 17, 2018.