Breast CancerPhase 2NCT02360059
Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer
A Phase 2 study testing Metformin, Questionnaires and Sensory and Fine-Motor Tests in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metformin, Questionnaires and Sensory and Fine-Motor Tests
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed invasive breast cancer, stage I - IV, treated at Lyndon B. Johnson General Hospital in the Harris Health System.
- Patients = or > 18 years old and < 75 years old.
- Patients scheduled to undergo paclitaxel chemotherapy for breast cancer.
- Patients with adequate renal function, as evidenced in laboratory values = or < 3 months old: epidermal growth factor receptor (eGFR) = or > 60 mL/min/1.73m2.
- Patients with adequate hepatic function per institutional testing standards, as evidenced in laboratory values = or < 3 months old: (1) The screening results for total bilirubin must be < 1.5 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 2 times the upper limit of normal.
- Patients who speak English and/or Spanish.
- Patients who are willing and able to review, understand, and provide written consent.
- Patients with an Eastern Cooperative Oncology performance status of 0 or 1.
Who cannot join
- Patients with a history of or known diagnosis of diabetes according to national guidelines (fasting plasma glucose > or = 126 mg/dL or random plasma glucose > or = 200 mg/dL), as evidenced in laboratory values < or = 3 months old).
- Patients using carbonic anhydrase inhibitors (acetazolamide [Diamox®], brinzolamide [Azopt®], methazolamide [Neptazane®], dorzolamide [Trusopt®], pomegranate ellagitannins), cimetidine, or topiramate.
- Patients who are enrolled in another symptom management trial.
- Patients with nerve pathology or clinically identified neuropathy.
- Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to the medication used in the study.
- Patients with any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association Class III or IV functional status, history of acidosis of any type).
Show all 12Show fewer
- Patients with intestinal issues, including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- Patients who are pregnant are excluded. Pre-menopausal women must have a negative pregnancy test. Patients that are post menopausal, or that have had a hysterectomy do not need to have a pregnancy test.
- Patients with any condition that precludes use of the study medication as determined by the treating physician.
- Patients with a diagnosis of hepatitis or HIV.
- Patients currently receiving or scheduled to receive a chemotherapy infusion other than Adriamycin/Cyclophosphamide prior to initiation of the metformin adaptation phase are not eligible. Patients who are receiving Adriamycin/Cyclophosphamide must be scheduled to be at least 8 days post-chemotherapy infusion prior to initiation of the metformin adaptation phase in order to be eligible.
- Patients who are currently using metformin (eg, Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
Official title: Metformin for Reduction of Paclitaxel Treatment-Related Neuropathy in Patients With Breast Cancer: A Randomized Pilot Study
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.
Read the detailed description
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.
- If you are in Group 1, you will take placebo pills.
- If you are in Group 2, you will take metformin pills.
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:
- You will complete questionnaires about numbness and other symptoms. It should take about 15 minutes to complete these questionnaires.
- You will complete 3 sensory and fine-motor tests. These tests will show researchers how sensitive you are to touching things such as small bumps and how well you are able to pick up small objects. It should take about 15 minutes to complete these tests.
- If possible, blood (about 8 teaspoons) will also be drawn to test for markers of inflammation. Markers of inflammation are biomarkers found in the blood and may be related to the symptoms you have. These blood samples during the study will only be collected if they can be drawn during a routine blood draw you are already having.
At 1-2 days before you start paclitaxel:
- You will complete the questionnaires about numbness and other symptoms.
- You will complete the sensory and fine-motor tests.
- 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.
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:
- You will complete the questionnaires about numbness.
- You will also complete the sensory and fine-motor dexterity tests.
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:
- You will complete the questionnaires about numbness and other symptoms.
- You will complete the sensory and fine-motor tests.
- 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.
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.
- Conditions
- Breast Cancer
- Being tested
- Metformin, Placebo, Questionnaires, Sensory and Fine-Motor Tests
- Keywords
- Breast cancer, Neuropathy, Paclitaxel, Metformin, Metformin ER, Placebo, Sugar pill, Questionnaires, Sensory tests, Fine-motor tests, Surveys
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metformin ER
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.
PlaceboOther
Also called Sugar pill
Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
QuestionnairesBehavioural
Also called Surveys
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.
Sensory and Fine-Motor TestsOther
Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Experimental | 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. Receives: Drug: Metformin; Behavioral: Questionnaires; Other: Sensory and Fine-Motor Tests |
| Placebo Group | Placebo comparator | 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. Receives: Other: Placebo; Behavioral: Questionnaires; Other: Sensory and Fine-Motor Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David L. Ramirez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360059
- Sponsor's protocol ID
- 2014-0438
- Other IDs
- NCI-2015-00510
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2015
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for Reduction of Paclitaxel Treatment-Related Neuropathy in Patients With Breast Cancer: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02360059
- Acronym / sponsor ID
- 2014-0438
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neuropathy, Paclitaxel, Metformin, Metformin ER, Placebo, Sugar pill, Questionnaires
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- If you are in Group 1, you will take placebo pills.
- If you are in Group 2, you will take metformin pills.
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:
- You will complete questionnaires about numbness and other symptoms. It should take about 15 minutes to complete these questionnaires.
- You will complete 3 sensory and fine-motor tests. These tests will show researchers how sensitive you are to touching things such as small bumps and how well you are able to pick up small objects. It should take about 15 minutes to complete these tests.
- If possible, blood (about 8 teaspoons) will also be drawn to test for markers of inflammation. Markers of inflammation are biomarkers found in the blood and may be related to the symptoms you have. These blood samples during the study will only be collected if they can be drawn during a routine blood draw you are already having.
At 1-2 days before you start paclitaxel:
- You will complete the questionnaires about numbness and other symptoms.
- You will complete the sensory and fine-motor tests.
- 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.
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:
- You will complete the questionnaires about numbness.
- You will also complete the sensory and fine-motor dexterity tests.
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:
- You will complete the questionnaires about numbness and other symptoms.
- You will complete the sensory and fine-motor tests.
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Experimental | Drug: Metformin, Behavioral: Questionnaires, Other: Sensory and Fine-Motor TestsParticipants 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. |
| Placebo Group | Placebo comparator | Other: Placebo, Behavioral: Questionnaires, Other: Sensory and Fine-Motor TestsParticipants 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed invasive breast cancer, stage I - IV, treated at Lyndon B. Johnson General Hospital in the Harris Health System.
- Patients = or > 18 years old and < 75 years old.
- Patients scheduled to undergo paclitaxel chemotherapy for breast cancer.
- Patients with adequate renal function, as evidenced in laboratory values = or < 3 months old: epidermal growth factor receptor (eGFR) = or > 60 mL/min/1.73m2.
- Patients with adequate hepatic function per institutional testing standards, as evidenced in laboratory values = or < 3 months old: (1) The screening results for total bilirubin must be < 1.5 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 2 times the upper limit of normal.
Key exclusion criteria (12 listed)
- Patients with a history of or known diagnosis of diabetes according to national guidelines (fasting plasma glucose > or = 126 mg/dL or random plasma glucose > or = 200 mg/dL), as evidenced in laboratory values < or = 3 months old).
- Patients using carbonic anhydrase inhibitors (acetazolamide [Diamox®], brinzolamide [Azopt®], methazolamide [Neptazane®], dorzolamide [Trusopt®], pomegranate ellagitannins), cimetidine, or topiramate.
- Patients who are enrolled in another symptom management trial.
- Patients with nerve pathology or clinically identified neuropathy.
- Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to the medication used in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Metformin ERMetformin 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. | Drug | Metformin Group |
| PlaceboAlso: Sugar pillParticipants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment. | Other | Placebo Group |
| QuestionnairesAlso: SurveysQuestionnaires 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. | Behavioural | Metformin Group, Placebo Group |
| Sensory and Fine-Motor TestsThree sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit. | Other | Metformin Group, Placebo Group |
Primary outcome
Mean Change in Neuropathy
Time frame: Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Ramirez, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Questionnaires and Sensory and Fine-Motor Tests in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Neuropathy (time frame: Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.