Breast Cancer Clinical Trial
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.
II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).
III. To examine the possible relative toxicities related to minocycline therapy in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of the study, patients are followed up every month for 6 months.
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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There are 12 Locations for this study
Pismo Beach California, 93449, United States
Normal Illinois, 61761, United States
Urbana Illinois, 61801, United States
Sioux City Iowa, 51101, United States
Ann Arbor Michigan, 48106, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Omaha Nebraska, 68106, United States
East Syracuse New York, 13057, United States
Winston-Salem North Carolina, 27103, United States
Providence Rhode Island, 02905, United States
Marshfield Wisconsin, 54449, United States
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