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The goal of this clinical trial is to assess the feasibility of adding a combination of metformin and turmeric as part of a nutritional intervention regimen to the current standard of care, namely, intermittent Androgen Deprivation Therapy (iADT), for patients with castration sensitive biochemical progressive prostate cancer.
The main objectives are:
Participants who are receiving iADT will be dispensed Metformin and turmeric and complete a pill diary. Participants will also have blood and stool samples collected and complete quality of life questionnaires.
The long-term goal is to further assess the efficacy and safety of this nutritional regimen and the roles of metabolic syndrome, microenvironment/microbiome, and genomic vs epigenomic profiles in the care of these patients through a clinical trial.
The purpose of this research is to determine if a nutritional plan of metformin and turmeric is feasible for individuals receiving iADT for prostate cancer. Turmeric is an over-the-counter supplement that is believed to provide anti-inflammatory effects. Metformin is an FDA-approved medication for diabetes to help lower blood sugar. This feasibility study will be conducted according to the standard of care (SoC) for eligible subjects receiving iADT but coordinated and streamlined in a prospective manner to care for subjects while collecting and annotating data for the duration of their care.
All subjects will receive iADT + turmeric + metformin + dietary consultation.
SoC laboratory tests will be performed in accordance with clinical practice for the care of patients with prostate cancer on or off iADT. Additional vials of blood will be collected for research purposes in order to assess epigenetic biomarkers, CSC biomarkers, and cancer dormancy biomarkers. Stool samples will be used to obtain microbiome profiles. QOL instruments (FACT-P and AMS) will also be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + Turmeric | Experimental | Each subject will begin using metformin and turmeric within 7 days of consent. Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved. After two weeks of metformin titration, each subject will start with 1,500 mg turmeric po daily with meals. Dose can be temporarily reduced to 1,000 mg po daily for those who report GI discomfort. If GI discomfort has resolved within one month of the dose reduction, subjects will resume 1,500 mg po daily. If GI discomfort has not resolved the participant may be insturcted to stop taking the study treatment and be removed from the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess feasibility of recruitment | Assessed using frequency (in percentage) of the number of subjects enrolled in the first six and twelve months out of the total desired accrual | 12 months of enrollment being open |
| Evaluate time to PSA relapse with nutritional intervention on iADT. | Observed from the time of consent to the time of PSA relapse or at the end of the study period (i.e., 27 months), whichever comes first. A survival curve will be used to estimate the accumulated rate of PSA relapse over time (over 27 months). | up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Version 4. | Obtain Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 0-156. Higher scores indicate better outcome. | up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expression levels of Metabolomic biomarkers from blood samples | Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 16 months, and will be summarized using mean ± standard deviation and/or median (min, max) | up to 16 months |
| Expression levels of CSC biomarkers including EMT and miRNAS from blood samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison Trujillo | Contact | 5016868274 | MTrujillo@uams.edu | |
| Aaron Holley | Contact | 5016868274 | jaholley@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shi-Ming Tu, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
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|
| Turmeric | Drug | Each subject will start with 1,500 mg turmeric po daily with meals. The dose can be temporarily reduced to 1,000 mg po daily for those who report GI discomfort. If GI discomfort has resolved within one month of the dose reduction, subjects will resume 1,500 mg po daily. If GI discomfort has not resolved or resumes at increased dose, the subject may be instructed to stop taking the study treatment and removed from the study. |
|
| Quality of Life (QOL) assessed by the Aging Male Symptoms Questionnaire (AMS Questionnaire). | Obtain Aging Male Symptoms Questionnaire (AMS Questionnaire) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 17-85. Higher scores indicate worse outcome. | up to 27 months |
Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 16 months, and will be summarized using mean ± standard deviation and/or median (min, max) |
| up to 16 months |
| Expression levels of Cancer dormancy Biomarkers (miR-200s, TGF-beta, BMPs, immune and inflammatory factors) from blood samples | Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 16 months, and will be summarized using mean ± standard deviation and/or median (min, max) | up to 16 months |
| Microbiome profiling from the stool samples to assess gut microbiome | Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 16 months, and will be summarized using mean ± standard deviation and/or median (min, max) | up to 16 months |
| ID | Term |
|---|---|
| D008687 | Metformin |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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