NCT02297412

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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

• Acute Pain
• Breast Carcinoma
• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Minocycline Hydrochloride	Given PO
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-08
• Completion: 2016-07-08
• First posted: 2014-11-21
• Last updated: 2022-01-31
• Results posted: 2018-11-07

Locations

12 sites across 1 country: United States