Survivorship Promotion In Reducing IGF-1 Trial
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
Checked against the public recordLast updated Aug 28, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Interventions being studied
- Drug: Metformin; Behavioral: Coach Directed Behavioral Weight Loss; Behavioral: Self-control weight loss
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Johns Hopkins ProHealthBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2024. Always confirm current availability with the study team.