Survivorship Promotion In Reducing IGF-1 Trial
Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors
Study Arms / Comparison Groups
Description: In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Women and men ages 18 or older - Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted. - Have a BMI of 25 kg/m^2 or greater and weight <=400 lbs. - Willingness to accept randomization to each of the three arms - Willingness to change diet, physical activity, and weight - Regular access to computer with a reliable Internet connection - Ability to send and receive emails - Ability to complete online forms - Access to phone - Willingness to provide written informed consent Exclusion Criteria: - Women who are breastfeeding, pregnant, or planning pregnancy within the next year - Medication-treated diabetes - Fasting blood glucose >=200 mg/dL, or fasting blood glucose >=126 and <200 mg/dL and HbA1C >=7% - Current or prior regular use of metformin within the past 3 months - Uncontrolled concurrent medical condition likely to limit compliance with the study interventions - Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date - Have a prior history of lactic acidosis by self-report - Prior or planned bariatric surgery - Have significant renal disease or dysfunction defined as Estimated glomerular filtration rate (eGFR)<45 - Have significant hepatic dysfunction [Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (ULN) or reported liver disease] - Self-reported average consumption of > 14 alcoholic drink per week - Currently enrolled or planned to enroll in weight loss program - Hemoglobin <9 g/dl - Platelet count <100 - White blood cell count (WBC) <2.5 - Plans to relocate from the area within one years - Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.
18 Years - N/A
Accepts Healthy Volunteers
Jessica Yeh, PhD, ,
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Maryland Cigarette Restitution Fund
Jessica Yeh, PhD, Principal Investigator, Johns Hopkins University