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
Information source: Academic and Community Cancer Research United
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Minocycline (Drug); Placebo (Drug)
Phase: Phase 0
Status: Active, not recruiting
Sponsored by: Academic and Community Cancer Research United Official(s) and/or principal investigator(s): Charles Loprinzi, M.D., Study Chair, Affiliation: Mayo Clinic
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Effectiveness of minocycline in paclitaxel-induced peripheral neuropathy as assessed by Quality of Life Questionnaires
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Palchak David MD, Pismo Beach, California 93449, United States
Illinois Cancer Care, PC, Peoria, Illinois 61615, United States
Carle Cancer Center, Urbana, Illinois 61801, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa 50309, United States
Siouxland Hematology - Oncology Associates, LLP, Sioux City, Iowa 51101, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan 48106, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Coborn Cancer Center / CentraCare Clinic, St. Cloud, Minnesota 56303, United States
Metro-Minnesota Community Clinical Oncology Program (CCOP), St. Louis Park, Minnesota 55426, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Hematology Oncology Associates of Central New York PC, East Syracuse, New York 13057, United States
Novant Health Presbyterian Medical Center - SECCC, Charlotte, North Carolina 28204, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Margaret R. Pardee Mem. Hospital - SECCC, Hendersonville, North Carolina 28791, United States
Novant Health Forsyth Medical Center - SECCC, Winston-Salem, North Carolina 27103, United States
Altru Cancer Center, Grand Forks, North Dakota 58201, United States
Women and Infants Hospital, Providence, Rhode Island 02905, United States
AnMed Health - SECCC, Anderson, South Carolina 29621, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States
Additional Information
Starting date: November 2014
Last updated: July 22, 2015
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