Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
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
3 other identifiers
interventional
47
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2014
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2016
CompletedResults Posted
Study results publicly available
November 7, 2018
CompletedJanuary 31, 2022
January 1, 2022
1.7 years
November 14, 2014
August 17, 2018
January 28, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)
Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Up to 12 weeks
Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.
Up to course 12
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.
Baseline to up to 12 weeks
Study Arms (2)
Arm I (minocycline hydrochloride)
EXPERIMENTALPatients 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.
Arm II (placebo)
PLACEBO COMPARATORPatients 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.
Interventions
Given PO
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
PCR Oncology
Pismo Beach, California, 93449, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles L. Loprinzi, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Loprinzi
Academic and Community Cancer Research United
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 21, 2014
Study Start
November 1, 2014
Primary Completion
July 8, 2016
Study Completion
July 8, 2016
Last Updated
January 31, 2022
Results First Posted
November 7, 2018
Record last verified: 2022-01