The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Charles Loprinzi
Affiliation: Academic and Community Cancer Research United
Role: PRINCIPAL_INVESTIGATOR