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



Status:Completed
Conditions:Breast Cancer, Cancer, Chronic Pain, Neurology
Therapuetic Areas:Musculoskeletal, Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/9/2018
Start Date:November 2014
End Date:July 8, 2016

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Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial

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.

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.

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
We found this trial at
12
sites
Sioux City, Iowa 51101
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Ann Arbor, Michigan 48106
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Ann Arbor, MI
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East Syracuse, NY
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Marshfield, Wisconsin 54449
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Marshfield, WI
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407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
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Normal, IL
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Omaha, Nebraska 68106
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Omaha, NE
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Pismo Beach, California 93449
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Pismo Beach, CA
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Providence, Rhode Island 02905
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Providence, RI
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Cloud, Minnesota 56303
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Saint Cloud, MN
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Urbana, IL
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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