Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Academic and Community Cancer Research United
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
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