Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Prostate Cancer; Lung Cancer; Colon Cancer; Melanoma of Skin; Endometrial Cancer; Liver Cancer; Pancreatic Cancer; Rectal Cancer; Kidney Cancer; Other Solid Malignant Tumors	Drug: Metformin; Behavioral: Coach Directed Behavioral Weight Loss; Behavioral: Self-control weight loss	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	121 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
Study Start Date :	May 2015
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: Self-control weight loss
Experimental: Coach Directed Behavioral Weight Loss; The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight	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
Experimental: Metformin; This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. IGF-1 levels [ Time Frame: 6 months ]
   IGF-1 levels among coach-directed behavioral weight loss arm or Metformin arm compare to the self-directed weight loss arm at 6 months
2. IGF-1 levels :IGFBP3 levels (Ratio) [ Time Frame: 6 months ]
   IGF-1: IGFBP3 ratio among coach-directed behavioral weight loss arm or Metformin arm compare than those in the self-directed weight loss arm at 6 months

Secondary Outcome Measures :

1. IGF-1 levels [ Time Frame: 12 months ]
   IGF-1the Metformin arm or Coach-directed behavioral weight loss arm compare to those in the self-directed weight loss arm at 12 months
2. IGF-1 levels :IGFBP3 levels (Ratio) [ Time Frame: 12 months ]
   IGF-1:IGFBP3 among the Metformin arm or coach-directed behavioral weight loss arm compare to those in the self-directed weight loss arm at 12 months

Other Outcome Measures:

1. Weight measured by scale(Kg) [ Time Frame: 6 & 12 months ]
   Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months
2. Body Mass Index measured by scale and tap(kg/m2) [ Time Frame: 6 & 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.
3. EuroQol score assessed by questionnaire [ Time Frame: 6 & 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.
4. Dietary intake assessed by questionnaire [ Time Frame: 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.
5. Physical Activity amount assessed by questionnaire [ Time Frame: 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.
6. Fasting Glucose levels [ Time Frame: 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.
7. Insulin levels [ Time Frame: 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.
8. Hemoglobin A1C levels [ Time Frame: 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.
9. Interleukin 6 levels [ Time Frame: 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.
10. Interleukin 8 levels [ Time Frame: 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.
11. CRP levels [ Time Frame: 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.
12. Side effects assessed by side effect questionnaire [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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- LHRH therapy for prostate cancer in men will be permitted.
• Have a BMI of 25 kg/m2 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 eGFR<45
• Have significant hepatic dysfunction (AST/ALT ≥ 2 x 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
• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Maryland
Johns Hopkins ProHealth
Baltimore, Maryland, United States, 21207

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Investigators

Principal Investigator:	Jessica Yeh, PhD	Johns Hopkins University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT02431676 History of Changes
Other Study ID Numbers:	J14148; IRB00035653 ( Other Identifier: JHMIRB )
First Posted:	May 1, 2015
Last Update Posted:	April 18, 2018
Last Verified:	April 2018

Additional relevant MeSH terms:

Pancreatic Neoplasms; Liver Neoplasms; Endometrial Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Uterine Neoplasms	Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs