Objectives: This randomized phase III trial asks whether a "MEAL program intervention," including dietary education and telephone counseling sessions over 24 months, can alter disease progression when compared with information on standard U.S. Dietary Guidelines.
Key entry or exclusion criteria: Patients should be 50-80 years of age with biopsy-proven disease up to clinical stage T2a and no distant metastases.
Locations: 120 sites.
Goal: 464 patients.
Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT01238172
NIH clinical trials identifier: NCT01238172