Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

• Status: Completed
• Trial end date: 2016-07-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academic and Community Cancer Research United
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Minocycline; Paclitaxel

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