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Recruiting NCT05802121

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Early Phase I Interventional Prostate Cancer Metabolic Syndrome Obesity Cardiovascular Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apple Cider Vinegar.
Who it may be relevant to
Registry conditions: Prostate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer

Overview

The overriding objectives of this study are: 1. Primary outcomes: 1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to a standard of care arm. 2. To confirm tolerability and assess for side effects of oral acetate supplementation. 2. Secondary outcomes: 1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

Interventions

  • Drug Apple Cider Vinegar
    Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433) https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o

Primary outcome measures

  • Fecal Akkermansia muciniphilia counts [Time frame: 1 week]
  • Fecal Akkermansia muciniphilia counts [Time frame: 1 month]
  • Fecal Akkermansia muciniphilia counts [Time frame: 3 month]
  • Fecal Akkermansia muciniphilia counts [Time frame: 4 month]
  • Fecal Akkermansia muciniphilia counts [Time frame: 6 month]
  • Side effects and tolerability [Time frame: 3 months]
Secondary outcome measures (12)
  • Metabolic parameters: fasting plasma glucose [Time frame: 3 months]
  • Metabolic parameters: fasting plasma glucose [Time frame: 6 months]
  • Metabolic parameters: HbA1C [Time frame: 3 months]
  • Metabolic parameters: HbA1c [Time frame: 6 months]
  • Metabolic parameters: triglycerides [Time frame: 3 months]
  • Metabolic parameters: triglycerides [Time frame: 6 months]
  • Metabolic parameters: LDL cholesterol [Time frame: 3 months]
  • Metabolic parameters: LDL cholesterol [Time frame: 6 months]
  • Metabolic parameters: HDL cholesterol [Time frame: 3 months]
  • Metabolic parameters: HDL cholesterol [Time frame: 6 months]
  • Metabolic parameters: total cholesterol [Time frame: 3 months]
  • Metabolic parameters: total cholesterol [Time frame: 6 months]

Eligibility criteria

For inclusion in this study, patients must fulfill all of the following criteria:

  • Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).
  • Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan

Patients fulfilling any of the following criteria are NOT eligible for participation in this study:

  • Age less than 18
  • Primary neuroendocrine prostate cancer
  • Treatment with ADT within the year leading up to enrolment
  • Planned or concurrent use of chromium supplementation for the study duration
  • Planned or concurrent use of apple cider vinegar supplementation for the study duration
  • Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
  • Inadequate liver function (>2x upper limit of normal)
  • Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
  • Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • London Health Sciences Centre - Victoria Hospital — London

Publications

  • McKay RR, Feng FY, Wang AY, Wallis CJD, Moses KA. Recent Advances in the Management of High-Risk Localized Prostate Cancer: Local Therapy, Systemic Therapy, and Biomarkers to Guide Treatment Decisions. Am Soc Clin Oncol Educ Book. 2020 May;40:1-12. doi: 10.1200/EDBK_279459. PMID 32412803
  • Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299. PMID 11836291
  • Timilshina N, Breunis H, Alibhai SM. Impact of androgen deprivation therapy on weight gain differs by age in men with nonmetastatic prostate cancer. J Urol. 2012 Dec;188(6):2183-8. doi: 10.1016/j.juro.2012.08.018. Epub 2012 Oct 18. PMID 23083859
  • Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741. PMID 16921050
  • Seible DM, Gu X, Hyatt AS, Beard CJ, Choueiri TK, Efstathiou JA, Miyamoto DT, Mitin T, Martin NE, Sweeney CJ, Trinh QD, Beckman JA, Basaria S, Nguyen PL. Weight gain on androgen deprivation therapy: which patients are at highest risk? Urology. 2014 Jun;83(6):1316-21. doi: 10.1016/j.urology.2014.02.006. Epub 2014 Apr 13. PMID 24726149
  • Sturgeon KM, Deng L, Bluethmann SM, Zhou S, Trifiletti DM, Jiang C, Kelly SP, Zaorsky NG. A population-based study of cardiovascular disease mortality risk in US cancer patients. Eur Heart J. 2019 Dec 21;40(48):3889-3897. doi: 10.1093/eurheartj/ehz766. PMID 31761945
  • Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500. doi: 10.1002/cncr.22933. PMID 17657815
  • Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497. PMID 16983113

Identifiers

NCT: NCT05802121 · ReDA ID 12558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗