Breast Cancer, Colon Cancer, Endometrial Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Melanoma of Skin, Other Solid Malignant Tumors, Pancreatic Cancer, Prostate Cancer, Rectal Cancer
Conditions
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
Interventions
DRUGMetformin
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.
BEHAVIORALCoach Directed Behavioral Weight Loss
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
BEHAVIORALSelf-control weight loss
Sponsors
Maryland Cigarette Restitution Fund
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 Levels | 6 months | Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 Levels | 12 months | IGF-1 at 12 months |
| IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | 6 months | IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake Assessed by Questionnaire | 6 and 12 months | Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Physical Activity Amount Assessed by Questionnaire | 6 and 12 months | Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Fasting Glucose Levels | 6 and 12 months | Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Insulin Levels | 6 and 12 months | Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Weight Measured by Scale(Kg) | 6 and 12 months | Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months |
| Interleukin (IL)-6 Levels | 6 and 12 months | Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Interleukin 8 Levels | 6 and 12 months | Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| C-reactive Protein (CRP) Levels | 6 and 12 months | Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Side Effects Assessed by Side Effect Questionnaire | 6 and 12 months | assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| Hemoglobin A1C Levels | 6 and 12 months | Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months. |
| Body Mass Index Measured by Scale and Tap(kg/m2) | 6 and 12 months | Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
| EuroQol Score Assessed by Questionnaire | 6 and 12 months | Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-Directed 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.
Self-control weight loss | 40 |
| Coach Directed Behavioral Weight Loss The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: 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 | 39 |
| Metformin This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: 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. | 42 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | no lab obtained | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Self-Directed | Coach Directed Behavioral Weight Loss | Metformin | Total |
|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 8.5 | 60.9 years STANDARD_DEVIATION 9.7 | 59.5 years STANDARD_DEVIATION 9 | 59.7 years STANDARD_DEVIATION 9 |
| BMI | 34.7 kg/m^2 STANDARD_DEVIATION 4.9 | 35.5 kg/m^2 STANDARD_DEVIATION 5 | 35.0 kg/m^2 STANDARD_DEVIATION 6.3 | 35.0 kg/m^2 STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Black | 18 Participants | 17 Participants | 20 Participants | 55 Participants |
| Race/Ethnicity, Customized Other non-black races | 22 Participants | 22 Participants | 22 Participants | 66 Participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 32 Participants | 96 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 39 | 0 / 42 |
| other Total, other adverse events | 10 / 40 | 3 / 39 | 6 / 42 |
| serious Total, serious adverse events | 5 / 40 | 5 / 39 | 12 / 42 |
Outcome results
Primary
IGF-1 Levels
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Directed | IGF-1 Levels | 73.2 ng/ml | Standard Deviation 19.9 |
| Coach Directed Behavioral Weight Loss | IGF-1 Levels | 73.6 ng/ml | Standard Deviation 20.9 |
| Metformin | IGF-1 Levels | 71.2 ng/ml | Standard Deviation 21.4 |
Secondary
IGF-1 Levels
IGF-1 at 12 months
Time frame: 12 months
Population: Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 37 in the metformin arm for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Directed | IGF-1 Levels | 73.4 ng/ml | Standard Deviation 20.7 |
| Coach Directed Behavioral Weight Loss | IGF-1 Levels | 76.6 ng/ml | Standard Deviation 25.7 |
| Metformin | IGF-1 Levels | 76.2 ng/ml | Standard Deviation 25.7 |
Secondary
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)
IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.
Time frame: 6 months
Population: Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 36 in the metformin arm for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Directed | IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | 0.18 ratio | Standard Deviation 0.047 |
| Coach Directed Behavioral Weight Loss | IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | 0.18 ratio | Standard Deviation 0.065 |
| Metformin | IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | 0.17 ratio | Standard Deviation 0.046 |
Other Pre-specified
Body Mass Index Measured by Scale and Tap(kg/m2)
Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
C-reactive Protein (CRP) Levels
Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Dietary Intake Assessed by Questionnaire
Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
EuroQol Score Assessed by Questionnaire
Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Fasting Glucose Levels
Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Hemoglobin A1C Levels
Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Insulin Levels
Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Interleukin 8 Levels
Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Interleukin (IL)-6 Levels
Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Physical Activity Amount Assessed by Questionnaire
Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Side Effects Assessed by Side Effect Questionnaire
assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Time frame: 6 and 12 months
Other Pre-specified
Weight Measured by Scale(Kg)
Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months
Time frame: 6 and 12 months