Survivorship Promotion In Reducing IGF-1 Trial
Condition: Breast Cancer; Prostate Cancer; Lung Cancer; Colon Cancer; Melanoma of Skin; Endometrial Cancer; Liver Cancer; Pancreatic Cancer; Rectal Cancer; Kidney Cancer; Other Solid Malignant Tumors
MeSH terms: Endometrial Neoplasms; Kidney Neoplasms
Intervention: Metformin; Coach Directed Behavioral Weight Loss; Self-control weight loss
Intervention description: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.; Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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.