Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial

Overview

About this study

The purpose of this study is to compare the effects, good and/or bad, of minocycline with placebo (an inactive agent) on symptoms caused by paclitaxel. In this study, the participant will get the minocycline or a placebo starting on the morning of the first dose of chemotherapy and continuing twice a day until a week after chemotherapy is finished.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Ability to complete questionnaires by themselves or with assistance
  • Planned paclitaxel at a dose of 80 mg/m2 I.V. given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
  • Life expectancy >6 months
  • ECOG performance status 0 or 1. (Form is available on the ACCRU web site https://www.accru.org/accru/forms/NonProtocolSpecificForms/index.html)
  • Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion).

Exclusion Criteria:

  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
  • Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause.
  • History of allergic or other adverse reactions to minocycline
  • Prior exposure to neurotoxic chemotherapy.
  • Diagnosis of fibromyalgia.
  • Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20202717

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