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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Peripheral Neuropathy; Breast Carcinoma; Acute Pain

Treatments: Other: Quality-of-Life Assessment; Drug: Minocycline Hydrochloride; Other: Questionnaire Administration; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02297412

P30CA015083 (U.S. NIH Grant/Contract)

RU221408I (Other Identifier)

NCI-2016-01592 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

Arm I (minocycline hydrochloride)

Experimental group

Description:

Patients receive minocycline hydrochloride 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.

Treatment:

Other: Questionnaire Administration

Drug: Minocycline Hydrochloride

Other: Quality-of-Life Assessment

Arm II (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Placebo

Other: Quality-of-Life Assessment