Phase 2
N=121
Survivorship Promotion In Reducing IGF-1 Trial
Breast Cancer · Prostate Cancer · Lung Cancer · Colon Cancer · Melanoma of Skin
Bottom Line
View on ClinicalTrials.gov: NCT02431676 ↗Enrolled (actual)
121
Serious AEs
18.2%
Results posted
Sep 2020
Primary outcome: Primary: IGF-1 Levels — 73.2; 73.6; 71.2 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug); Coach Directed Behavioral Weight Loss (Behavioral); Self-control weight loss (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IGF-1 Levels |
73.4; 76.6; 76.2 | — |
| SECONDARY IGF-1 Levels |
73.4; 76.6; 76.2 | — |
| SECONDARY IGF-1 to IGFBP3 Level Ratio (Molar Ratio) |
0.18; 0.18; 0.17 | — |
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 =200 mg/dL, or fasting blood glucose >=126 and =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) 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.
Data sourced from ClinicalTrials.gov (NCT02431676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.