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

Status: Completed
Location: See all (12) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
PCR Oncology
Pismo Beach
Iowa
Siouxland Regional Cancer Center
Sioux City
Illinois
Illinois CancerCare-Community Cancer Center
Normal
Carle Cancer Center
Urbana
Michigan
Michigan Cancer Research Consortium NCORP
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
North Carolina
Novant Health Oncology Specialists
Winston-salem
Nebraska
Missouri Valley Cancer Consortium
Omaha
New York
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Rhode Island
Women and Infants Hospital
Providence
Wisconsin
Marshfield Clinic
Marshfield
Time Frame
Start Date: 2014-11
Completion Date: 2016-07-08
Participants
Target number of participants: 47
Treatments
Experimental: Arm I (minocycline hydrochloride)
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.
Placebo_comparator: Arm II (placebo)
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.
Sponsors
Leads: Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials