Phase 2
N=47
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Acute Pain · Breast Carcinoma · Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02297412 ↗Enrolled (actual)
47
Serious AEs
8.9%
Results posted
Nov 2018
Primary outcome: Primary: Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire) — 96.0; 84.3 scores on a scale — p=0.0186
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Minocycline Hydrochloride (Drug); Placebo (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academic and Community Cancer Research United
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire) |
96.0; 84.3 | 0.0186 sig |
| PRIMARY Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale |
94.1; 89.4 | 0.1146 |
| PRIMARY Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire) |
76.7; 59.0 | 0.0243 sig |
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 Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02297412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.