Breast CancerPhase 2SPIRITNCT02431676
Survivorship Promotion In Reducing IGF-1 Trial
A Phase 2 study testing Metformin and Coach Directed Behavioral Weight Loss in people with Breast Cancer and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- Metformin and Coach Directed Behavioral Weight Loss
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2018
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to send and receive emails
- Ability to complete online forms
- Access to phone
- Willingness to provide written informed consent
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
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
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer, Melanoma of Skin, Endometrial Cancer
- Being tested
- Metformin, Coach Directed Behavioral Weight Loss, Self-control weight loss
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colonic Neoplasms, Melanoma, Endometrial Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
Coach Directed Behavioral Weight LossBehavioural
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 lossBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed | Active comparator | 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. Receives: Behavioral: Self-control weight loss |
| Coach Directed Behavioral Weight Loss | Experimental | The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight Receives: Behavioral: Coach Directed Behavioral Weight Loss |
| Metformin | Experimental | This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 Levels
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
Measured: 6 months
Secondary outcomes (2)
IGF-1 Levels
IGF-1 at 12 months
Measured: 12 months
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)
IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Responsible party
- Sponsor
- Investigators
- Jessica Yeh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431676
- Sponsor's protocol ID
- J14148
- Other IDs
- IRB00035653
- Acronym
- SPIRIT
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2015
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller E, White K, Appel LJ, Mueller NT. Increases in Circulating and Fecal Butyrate are Associated With Reduced Blood Pressure and Hypertension: Results From the SPIRIT Trial. J Am Heart Assoc. 2022 Jul 5;11(13):e024763. doi: 10.1161/JAHA.121.024763. Epub 2022 Jun 22.
PubMed 35730613Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller ER, Appel LJ, Mueller NT. A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial. Int J Obes (Lond). 2022 Mar;46(3):655-660. doi: 10.1038/s41366-021-01039-2. Epub 2022 Jan 6.
PubMed 34987204Hu JR, Yeh HC, Mueller NT, Appel LJ, Miller ER 3rd, Maruthur NM, Jerome GJ, Chang AR, Gelber AC, Juraschek SP. Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial. Nutrients. 2021 Jul 31;13(8):2673. doi: 10.3390/nu13082673.
PubMed 34444833Mueller NT, Differding MK, Zhang M, Maruthur NM, Juraschek SP, Miller ER 3rd, Appel LJ, Yeh HC. Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial. Diabetes Care. 2021 Jul;44(7):1462-1471. doi: 10.2337/dc20-2257. Epub 2021 May 18.
PubMed 34006565Juraschek SP, Plante TB, Charleston J, Miller ER, Yeh HC, Appel LJ, Jerome GJ, Gayles D, Durkin N, White K, Dalcin A, Hermosilla M. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018 Apr;15(2):130-138. doi: 10.1177/1740774517745829. Epub 2018 Jan 24.
PubMed 29361843