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Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT02360059
Recruitment Status : Terminated (Low Accrual)
First Posted : February 10, 2015
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Metformin
Other: Placebo
Behavioral: Questionnaires
Other: Sensory and Fine-Motor Tests
Enrollment 1
Recruitment Details Recruitment Period: October 06, 2015 to July 22, 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details Changes in breast cancer treatment and this study's requirement for a long rest-interval led to lower than expected accrual rate resulting in early study termination.
Arm/Group Title Metformin Group Placebo Group
Hide Arm/Group Description Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment. Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Metformin Group Placebo Group Total
Hide Arm/Group Description Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment. Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment. Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
1
 100.0%
Male
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Mean Change in Neuropathy
Hide Description Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas [AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights correspond to two adjoining symptom responses, number of trapezoids depends on number of symptom assessments and sum of area for all trapezoids represents AUC of particular participant]. QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) using a 4-point Likert scale (1 = “not at all,” 2 = “a little,” 3 = “quite a bit,” and 4 = “very much”) with the higher score denoting more symptom burden.
Time Frame Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Study stopped early with only one participant, analysis not possible.
Arm/Group Title Metformin Group Placebo Group
Hide Arm/Group Description:
Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.
Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data collected was up to 18.5 weeks (13.5 weeks of intervention and 4 ± 1week after end of treatment).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Group Placebo Group
Hide Arm/Group Description Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment. Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
All-Cause Mortality
Metformin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David L. Ramirez, Assistant Professor, Breast Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02360059     History of Changes
Other Study ID Numbers: 2014-0438
NCI-2015-00510 ( Registry Identifier: NCI CTRP )
First Submitted: February 5, 2015
First Posted: February 10, 2015
Results First Submitted: July 19, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017