Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minocycline Hydrochloride | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (minocycline hydrochloride)
- description
- 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.
- interventionNames
- Drug: Minocycline Hydrochloride
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- 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.
- interventionNames
- Other: Placebo
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available