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Spots Global Cancer Trial Database for Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

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Trial Identification

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

Official Title: 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

Study ID: NCT02297412

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

PCR Oncology, Pismo Beach, California, United States

Illinois CancerCare-Community Cancer Center, Normal, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States

Mayo Clinic, Rochester, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States

Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse, New York, United States

Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States

Women and Infants Hospital, Providence, Rhode Island, United States

Marshfield Clinic, Marshfield, Wisconsin, United States

Contact Details

Name: Charles Loprinzi

Affiliation: Academic and Community Cancer Research United

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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