A Phase 2 interventional study of Metformin and Placebo in Breast Cancer, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-08-17.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if metformin can help to control nerve damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in patients with breast cancer.
In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have a 1 out of 3 chance of being in Group 1 and a 2 out of 3 chance of being in Group 2.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
You should take the pills 2 times a day at about the same time every day, preferably with food (for example, with breakfast and dinner).
You will start taking the pills about 12 days before your paclitaxel treatment starts. This is called the "adaptation period." It is meant to allow your body to get used to the study pills. The study staff will check you for allergic reactions or other negative reactions to the pills during this period. If you are not tolerating the pills, you will be taken off study.
About every 3 weeks while you are receiving paclitaxel, you should bring the study drug/placebo container (along with any leftover pills) to the clinic. The study staff will count the number of pills you have taken.
Study Visits:
Every week during the study, either during your clinic visit or by phone, the study staff will ask you about any side effects you may be having, if you have taken the study drug/placebo, and how many pills you have taken so far. The calls should take about 10-15 minutes.
About 2 weeks before you start paclitaxel:
At 1-2 days before you start paclitaxel:
Every week while you are receiving paclitaxel, you will complete a questionnaire in the clinic or by phone about any symptoms you may be having, and how the symptoms may be affecting your daily activities. This questionnaire should take about 5 minutes to complete.
About every 3 weeks while you are receiving paclitaxel, at your clinic visits:
At about Weeks 6 and 12 while you are receiving paclitaxel, at your clinic visits, blood (about 8 teaspoons) will be drawn to test for markers of inflammation, if a routine blood sample is also being drawn on that day.
At about Week 12 while you are receiving paclitaxel, at your clinic visit, you will complete a questionnaire about how satisfied you are with the study drug/placebo. Completing the questionnaire should take about 5 minutes.
Length of Study:
You may take the study drug/placebo for up to 12 weeks. You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in the study will be over after the end-of-study visit.
End-of-Study Visit:
About 4 weeks after you finish receiving the study drug/placebo:
This is an investigational study. Metformin is FDA approved and commercially available for the treatment of a type of diabetes. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work.
Up to 42 participants will be enrolled in this study. All will take part at the Harris Health System.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment. Adaptation phase begins 12 days prior to the start of the Paclitaxel therapy. During this phase, study medication dose starts at 500 mg daily for 5 days, followed by 500 mg twice daily for 5 days, followed by the desired dose of 1,000 mg twice daily for 2 days. Participants reach required study medication dose of 2,000 mg daily 2 days prior to commencement of Paclitaxel therapy and continue this dose for remainder of intervention. Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel. Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.
Drug: Metformin · Behavioral: Questionnaires · Other: Sensory and Fine-Motor Tests
Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment. Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel. Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.
Other: Placebo · Behavioral: Questionnaires · Other: Sensory and Fine-Motor Tests
Metformin dose starts at 500 mg daily for 5 days, followed by 500 mg twice daily for 5 days, followed by 1,000 mg twice daily for 2 days. Participants reach required study medication dose of 2,000 mg daily 2 days prior to commencement of Paclitaxel therapy and continue this dose for remainder of intervention.
Also known as: Metformin ER
Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
Also known as: Sugar pill
Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel.
Also known as: Surveys
Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.
Mean Change in Neuropathy
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
Recruitment Period: October 06, 2015 to July 22, 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.
| Milestone | Metformin Group | Placebo Group |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Collected over Adverse event data collected was up to 18.5 weeks (13.5 weeks of intervention and 4 ± 1week after end of treatment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin Group | — | 0/1 (0%) | 0/1 (0%) |
| Placebo Group | — | — | — |
| Age, Categorical(Participants) | Metformin Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 1 | — | 1 |
| >=65 years | 0 | — | 0 |
| Sex: Female, Male(Participants) | Metformin Group | Placebo Group | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 0 | — | 0 |
| Region of Enrollment(participants) | Metformin Group | Placebo Group | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center