Breast CancerPhase 1/2NCT01815346
Acupuncture Chemotherapy-Induced Peripheral Neuropathy (CIPN) IRG
A Phase 1/2 study testing Acupuncture, Questionnaires and Hand Function and Balance 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 compare the level of effectiveness for 2 acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also want to study how patients may respond to acupuncture treatments, and how the treatments may affect quality of life, hand function… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture, Questionnaires and Hand Function and Balance Tests
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2014to 10 May 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- Age >/= 18 years.
- History of a diagnosis of breast cancer.
- Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients are allowed to stop medications but not replace them with other medications.
- The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments.
Who cannot join
- Current active treatment with chemotherapy , radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- Physical deformities that could interfere with accurate acupuncture point location.
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins.
- Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
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- Platelets < 50 H K/UL in the past 30 days.
- White blood cells (WBCs) < 3.0 K/UL or absolute neutrophil count (ANC) <1,500 K/UL) in the past 30 days.
- Active central nervous system (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
- Cardiac pacemaker.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
- Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
- History of diabetic neuropathy or neuropathy related to HIV.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
- Planned or actual changes in type of medications that could affect symptoms related to CIPN. New medications for the treatment of CIPN are not allowed during the study. Note: Subjects need to be on stable doses for 4 weeks.
- Grade III lymphedema or lymphedema considered severe by the treating clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I-II Study of Acupuncture for the Treatment of Chronic, Taxane-Induced Peripheral Neuropathy in Breast Cancer Survivors
The goal of this clinical research study is to compare the level of effectiveness for 2 acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also want to study how patients may respond to acupuncture treatments, and how the treatments may affect quality of life, hand function, balance, and the use of drugs for neuropathy pain.
Read the detailed description
Peripheral neuropathy is one of the most common chemotherapy side effects affecting the nerves. Each year, thousands of patients receive taxane-based chemotherapy and more than 50-60% of these patients will have CIPN. CIPN can cause painful or abnormal skin sensation (such as pins and needles), numbness, and/or nerve damage that may affect movement.
Baseline Visit:
You have already had certain tests as part of your routine care that helped show that you were eligible to take part in this study. If you agree to take part in this study, the following tests and procedures will be performed at your first study visit:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured.
- Your medical history will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may be having.
- You will complete 3 questionnaires about any symptoms you may have. The questionnaires should take about 15-30 minutes to complete in total.
- You will perform hand function and balance tests. For these tests, you will complete tasks such as putting pegs into a pegboard. These tests should take about 20 minutes to complete.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Both groups will receive a total of 12 acupuncture treatments.
- Group 1 will receive acupuncture 2 times a week for 6 weeks.
- Group 2 will receive acupuncture 3 times a week for 4 weeks.
Acupuncture Treatments (All Participants):
Your acupuncture treatments will be given on an outpatient basis in private rooms. For the treatment, you will lay down on a table face up. The acupuncturist will disinfect the selected acupuncture points with alcohol. Then, the acupuncture needles will be placed so that you achieve a "de qi" sensation, which is often described as an achy, tingling, or numb feeling of pressure after an acupuncture needle has been properly placed in the skin.
The acupuncture needles will be left in place for about 20 minutes. During this time, the needles will be charged with a small electric current, which is done to enhance the effect of the acupuncture treatment. The needles may also be twirled to cause the sensation of de qi.
During each treatment session, you will receive acupuncture to the arms, legs, and abdomen.
Study Visits:
One (1) time every week:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may be having.
At Weeks 3 and 6 (Group 1 only) and Weeks 2 and 4 (Group 2 only):
- You will complete the same 3 questionnaires you completed at baseline.
- You will perform hand function and balance tests.
Length of Study:
You may continue your participation on this study for up to 10 weeks, as long as the study doctor thinks it is your best interest. Your active participation in this study will be over after you have completed the 4-week follow-up visit.
Follow-Up:
Four (4) weeks after you complete the acupuncture treatment, the following tests and/or procedures will be performed:
- Your vital signs will be measured.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may be having.
- You will complete the same 3 questionnaires you completed at baseline.
- You will perform hand function and balance tests.
This is an investigational study. The acupuncture needles being used in this study are FDA approved for medical use. The use of acupuncture treatments for chronic CIPN on the schedules in this study is investigational.
Up to 54 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture, Questionnaires, Hand Function and Balance Tests
- Keywords
- Breast Cancer, Breast cancer survivors, Chronic, taxane-based chemotherapy-induced peripheral neuropathy, CIPN, Acupuncture treatments, Quality of life, Hand function, Balance, Questionnaires, Surveys
- Medical subject headings
- Breast Neoplasms, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
One group receives acupuncture 2 times a week for 6 weeks.
One group receives acupuncture 3 times a week for 4 weeks.
Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes.
QuestionnairesBehavioural
Also called Surveys
Three questionnaires completed at baseline, midpoint, and four weeks after completion of acupuncture treatment.
Hand Function and Balance TestsOther
Tests completed at baseline, midpoint, and four weeks after completion of acupuncture treatment. These tests should take about 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group - Twice a Week | Experimental | Acupuncture 2 times a week for 6 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes. Receives: Procedure: Acupuncture; Behavioral: Questionnaires; Other: Hand Function and Balance Tests |
| Acupuncture Group - Three Times a Week | Experimental | Acupuncture 3 times a week for 4 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes. Receives: Procedure: Acupuncture; Behavioral: Questionnaires; Other: Hand Function and Balance Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score Changes in Neurotoxicity Scale
Efficacy analysis used employing a paired t-test to estimate the mean changes in the score of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) Scale separately from baseline to after 12 treatments for each acupuncture schedule. 95% confidence intervals calculated for these estimates. T-test used to compare differences in scores (from baseline to after 12 treatments) between groups.
Measured: 4 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study start6 Jul 2014
- Primary completion10 May 2016
- Study completion10 May 2016
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kay Garcia, DRPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815346
- Sponsor's protocol ID
- 2012-1054
- Other IDs
- NCI-2014-01520
- Status last verified
- Jan 2018
- First submitted
- 15 Mar 2013
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Acupuncture for the Treatment of Chronic, Taxane-Induced Peripheral Neuropathy in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01815346
- Acronym / sponsor ID
- 2012-1054
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast cancer survivors, Chronic, taxane-based chemotherapy-induced peripheral neuropathy, CIPN, Acupuncture treatments, Quality of life, Hand function, Balance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Jul 2014 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 10 May 2016 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
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 compare the level of effectiveness for 2 acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also want to study how patients may respond to acupuncture treatments, and how the treatments may affect quality of life, hand function, balance, and the use of drugs for neuropathy pain.
Detailed description
Peripheral neuropathy is one of the most common chemotherapy side effects affecting the nerves. Each year, thousands of patients receive taxane-based chemotherapy and more than 50-60% of these patients will have CIPN. CIPN can cause painful or abnormal skin sensation (such as pins and needles), numbness, and/or nerve damage that may affect movement.
Baseline Visit:
You have already had certain tests as part of your routine care that helped show that you were eligible to take part in this study. If you agree to take part in this study, the following tests and procedures will be performed at your first study visit:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured.
- Your medical history will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may be having.
- You will complete 3 questionnaires about any symptoms you may have. The questionnaires should take about 15-30 minutes to complete in total.
- You will perform hand function and balance tests. For these tests, you will complete tasks such as putting pegs into a pegboard. These tests should take about 20 minutes to complete.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Both groups will receive a total of 12 acupuncture treatments.
- Group 1 will receive acupuncture 2 times a week for 6 weeks.
- Group 2 will receive acupuncture 3 times a week for 4 weeks.
Acupuncture Treatments (All Participants):
Your acupuncture treatments will be given on an outpatient basis in private rooms. For the treatment, you will lay down on a table face up. The acupuncturist will disinfect the selected acupuncture points with alcohol. Then, the acupuncture needles will be placed so that you achieve a "de qi" sensation, which is often described as an achy, tingling, or numb feeling of pressure after an acupuncture needle has been properly placed in the skin.
The acupuncture needles will be left in place for about 20 minutes. During this time, the needles will be charged with a small electric current, which is done to enhance the effect of the acupuncture treatment. The needles may also be twirled to cause the sensation of de qi.
During each treatment session, you will receive acupuncture to the arms, legs, and abdomen.
Study Visits:
One (1) time every week:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may be having.
At Weeks 3 and 6 (Group 1 only) and Weeks 2 and 4 (Group 2 only):
- You will complete the same 3 questionnaires you completed at baseline.
- You will perform hand function and balance tests.
Length of Study:
You may continue your participation on this study for up to 10 weeks, as long as the study doctor thinks it is your best interest. Your active participation in this study will be over after you have completed the 4-week follow-up visit.
Follow-Up:
Four (4) weeks after you complete the acupuncture treatment, the following tests and/or procedures will be performed:
- Your vital signs will be measured.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may be having.
- You will complete the same 3 questionnaires you completed at baseline.
- You will perform hand function and balance tests.
This is an investigational study. The acupuncture needles being used in this study are FDA approved for medical use. The use of acupuncture treatments for chronic CIPN on the schedules in this study is investigational.
Up to 54 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group - Twice a Week | Experimental | Procedure: Acupuncture, Behavioral: Questionnaires, Other: Hand Function and Balance TestsAcupuncture 2 times a week for 6 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes. |
| Acupuncture Group - Three Times a Week | Experimental | Procedure: Acupuncture, Behavioral: Questionnaires, Other: Hand Function and Balance TestsAcupuncture 3 times a week for 4 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- Age >/= 18 years.
- History of a diagnosis of breast cancer.
- Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients are allowed to stop medications but not replace them with other medications.
- The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team.
Key exclusion criteria (16 listed)
- Current active treatment with chemotherapy , radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- Physical deformities that could interfere with accurate acupuncture point location.
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins.
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 |
|---|---|---|
| AcupunctureOne group receives acupuncture 2 times a week for 6 weeks. One group receives acupuncture 3 times a week for 4 weeks. Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes. | Procedure or surgery | Acupuncture Group - Three Times a Week, Acupuncture Group - Twice a Week |
| QuestionnairesAlso: SurveysThree questionnaires completed at baseline, midpoint, and four weeks after completion of acupuncture treatment. | Behavioural | Acupuncture Group - Three Times a Week, Acupuncture Group - Twice a Week |
| Hand Function and Balance TestsTests completed at baseline, midpoint, and four weeks after completion of acupuncture treatment. These tests should take about 20 minutes to complete. | Other | Acupuncture Group - Three Times a Week, Acupuncture Group - Twice a Week |
Primary outcome
Score Changes in Neurotoxicity Scale
Time frame: 4 weeks and 6 weeks
Efficacy analysis used employing a paired t-test to estimate the mean changes in the score of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) Scale separately from baseline to after 12 treatments for each acupuncture schedule. 95% confidence intervals calculated for these estimates. T-test used to compare differences in scores (from baseline to after 12 treatments) between groups.
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- University of Texas MD Anderson Cancer CenterLink 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.
Kay Garcia, DRPH 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 1/2 study testing Acupuncture, Questionnaires and Hand Function and Balance 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 7 inclusion and 16 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 12 Jan 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Score Changes in Neurotoxicity Scale (time frame: 4 weeks and 6 weeks). 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 12 Jan 2018.