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Trial record 3 of 6 for:    "Neuromuscular Disease" | "Minocycline"

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

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ClinicalTrials.gov Identifier: NCT02297412
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Acute Pain
Breast Carcinoma
Peripheral Neuropathy
Interventions Drug: Minocycline Hydrochloride
Other: Placebo
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Hide Arm/Group 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. 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.
Period Title: Overall Study
Started 23 24
Completed 22 23
Not Completed 1 1
Reason Not Completed
Canceled             1             1
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo) Total
Hide Arm/Group 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 22 23 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 45 participants
54.8  (10.1) 55.0  (11.8) 54.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Female
22
 100.0%
23
 100.0%
45
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 23 participants 45 participants
22
 100.0%
23
 100.0%
45
 100.0%
1.Primary Outcome
Title Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)
Hide Description 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.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the Daily Post-Paclitaxel Questionnaire item 3 over 12 weeks were included in this analysis.
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: scores on a scale
96.0
(54.4 to 100.0)
84.3
(46.5 to 99.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Minocycline Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale
Hide Description 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.
Time Frame Up to course 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the EORTC Chemotherapy-Induced Peripheral Neurophathy Module Sensory Neuropathy Subscale items over 12 weeks were included in this analysis.
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 21 20
Median (Full Range)
Unit of Measure: scores on a scale
94.1
(58.7 to 100.0)
89.4
(68.7 to 98.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Minocycline Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1146
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)
Hide Description 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.
Time Frame Baseline to up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the Acute Pain Syndrome Summary Questionnaire over 12 weeks are included in this analysis.
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 21 21
Median (Full Range)
Unit of Measure: scores on a scale
76.7
(30.8 to 90.0)
59.0
(29.4 to 86.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Minocycline Hydrochloride), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0243
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Up to 12 weeks
Adverse Event Reporting Description The descriptions & grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT).
 
Arm/Group Title Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Hide Arm/Group 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. 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.
All-Cause Mortality
Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/22 (13.64%)      1/23 (4.35%)    
Infections and infestations     
Lung infection  1  1/22 (4.55%)  2 0/23 (0.00%)  0
Investigations     
Lymphocyte count decreased  1  2/22 (9.09%)  2 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  0/22 (0.00%)  0 1/23 (4.35%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Minocycline Hydrochloride) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/22 (36.36%)      9/23 (39.13%)    
Gastrointestinal disorders     
Abdominal pain  1  1/22 (4.55%)  1 1/23 (4.35%)  1
Diarrhea  1  1/22 (4.55%)  1 1/23 (4.35%)  1
General disorders     
Fatigue  1  2/22 (9.09%)  3 2/23 (8.70%)  2
Investigations     
Lymphocyte count decreased  1  2/22 (9.09%)  3 1/23 (4.35%)  1
Neutrophil count decreased  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Metabolism and nutrition disorders     
Hyponatremia  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/22 (0.00%)  0 2/23 (8.70%)  2
Back pain  1  1/22 (4.55%)  1 0/23 (0.00%)  0
Myalgia  1  0/22 (0.00%)  0 2/23 (8.70%)  10
Nervous system disorders     
Dizziness  1  1/22 (4.55%)  3 0/23 (0.00%)  0
Headache  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Peripheral sensory neuropathy  1  0/22 (0.00%)  0 2/23 (8.70%)  3
Skin and subcutaneous tissue disorders     
Pruritus  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Rash acneiform  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Rash maculo-papular  1  0/22 (0.00%)  0 2/23 (8.70%)  7
Vascular disorders     
Hypertension  1  0/22 (0.00%)  0 1/23 (4.35%)  1
Thromboembolic event  1  1/22 (4.55%)  1 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
Phone: 507/284-6026
EMail: cloprinzi@mayo.edu
Layout table for additonal information
Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT02297412     History of Changes
Other Study ID Numbers: RU221408I
NCI-2016-01592 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RU221408I ( Other Identifier: Academic and Community Cancer Research United )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2014
First Posted: November 21, 2014
Results First Submitted: August 17, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018