Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02297412
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2014-11-14
Brief Title:
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
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
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-01592 | REGISTRY | None | None |
| RU221408I | OTHER | None | None |
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |