Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Pain, Breast Carcinoma, Peripheral Neuropathy
In brief
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.
Key facts
- Study ID
- NCT02297412
- Run by
- Academic and Community Cancer Research United
- People needed
- 47
- Starts
- 2014-11-01
- Expected to finish
- 2016-07-08
- Last updated by the study team
- 2022-01-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to complete questionnaires by themselves or with assistance
- Planned paclitaxel at a dose of 80 mg/m2 IV 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)
You may not qualify if…
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- 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
- History of allergic or other adverse reactions to tetracycline
Where it is running
- PCR Oncology — Pismo Beach, California, United States
- Illinois CancerCare-Community Cancer Center — Normal, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Siouxland Regional Cancer Center — Sioux City, Iowa, United States
- Michigan Cancer Research Consortium NCORP — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
- Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
- Hematology Oncology Associates of Central New York-East Syracuse — East Syracuse, New York, United States
- Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
- Women and Infants Hospital — Providence, Rhode Island, United States
- Marshfield Clinic — Marshfield, Wisconsin, United States
Full record on ClinicalTrials.gov
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