Status:
COMPLETED
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Pain
Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy. II. To estimate whether minocycline can alleviate paclitaxe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02297412
Start Date
November 1 2014
End Date
July 8 2016
Last Update
January 31 2022
Active Locations (12)
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1
PCR Oncology
Pismo Beach, California, United States, 93449
2
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
3
Carle Cancer Center
Urbana, Illinois, United States, 61801
4
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101