Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT)
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ClinicalTrials.gov Identifier: NCT02431676 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 1, 2015
Last Update Posted
: April 18, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 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 |
Arm | Intervention/treatment |
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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.
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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
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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
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Experimental: Metformin
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
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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.
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- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431676
United States, Maryland | |
Johns Hopkins ProHealth | |
Baltimore, Maryland, United States, 21207 |
Principal Investigator: | Jessica Yeh, PhD | Johns Hopkins University |
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 Key Record Dates |
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 |