Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297412
• Other study ID #: RU221408I
• Secondary ID: NCI-2016-01592RU
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: July 8, 2016

Study information

• Verified date: January 2022
• Source: Academic and Community Cancer Research United
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 8, 2016
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Breast Carcinoma
• Breast Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Minocycline Hydrochloride
Given PO

Other:
• Placebo
Given PO
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan
United States	Hematology Oncology Associates of Central New York-East Syracuse	East Syracuse	New York
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Illinois CancerCare-Community Cancer Center	Normal	Illinois
United States	Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	PCR Oncology	Pismo Beach	California
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	Carle Cancer Center	Urbana	Illinois
United States	Novant Health Oncology Specialists	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Academic and Community Cancer Research United	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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