Brief Title
Survivorship Promotion In Reducing IGF-1 Trial
Official Title
Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
Brief 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
IGF-1 Levels
Secondary Outcome
IGF-1 Levels
Condition
Breast Cancer
Intervention
Metformin
Study Arms / Comparison Groups
Self-Directed
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
121
Start Date
May 2015
Completion Date
December 2018
Primary Completion Date
December 2018
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jessica Yeh, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02431676
Organization ID
J14148
Secondary IDs
IRB00035653
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Maryland Cigarette Restitution Fund
Study Sponsor
Jessica Yeh, PhD, Principal Investigator, Johns Hopkins University
Verification Date
August 2020