Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
NCT ID: NCT02297412
Last Updated: 2022-01-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2014-11-30
2016-07-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Minocycline Hydrochloride
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Minocycline Hydrochloride
Given PO
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Academic and Community Cancer Research United
OTHER
Responsible Party
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Principal Investigators
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Charles Loprinzi
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
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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
Countries
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Other Identifiers
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NCI-2016-01592
Identifier Type: REGISTRY
Identifier Source: secondary_id
RU221408I
Identifier Type: OTHER
Identifier Source: secondary_id
RU221408I
Identifier Type: -
Identifier Source: org_study_id
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