Survivorship Promotion In Reducing IGF-1 Trial

Breast Cancer Clinical Trial

— SPIRIT  

Official title:

Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431676
• Other study ID #: J14148
• Secondary ID: IRB00035653
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Liver Cancer
• Lung Cancer
• Melanoma of Skin
• Neoplasms
• Other Solid Malignant Tumors
• Pancreatic Cancer
• Prostate Cancer
• Rectal Cancer

Intervention

Drug:
• 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.

Behavioral:
• 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
• Self-control weight loss

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Maryland Cigarette Restitution Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Other	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.	6 and 12 months
Primary	IGF-1 Levels	Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.	6 months
Secondary	IGF-1 Levels	IGF-1 at 12 months	12 months
Secondary	IGF-1 to IGFBP3 Level Ratio (Molar Ratio)	IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.	6 months