Survivorship Promotion In Reducing IGF-1 Trial

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Maryland Cigarette Restitution Fund
• Treatments: Metformin

Criteria

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.