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A Phase I-II Study of Acupuncture for the Treatment of Chronic, Taxane-Induced Peripheral Neuropathy in Breast Cancer Survivors


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase I-II Study of Acupuncture for the Treatment of Chronic, Taxane-Induced Peripheral Neuropathy in Breast Cancer Survivors


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:

Patient may have already had certain tests as part of their routine care that helped show
that they were eligible to take part in this study. If patient agrees to take part in this
study, the following tests and procedures will be performed at their first study visit:

- Patient's vital signs (blood pressure, heart rate, temperature, and breathing rate)
will be measured.

- Patient's medical history will be recorded.

- Patient will be asked about any drugs they may be taking and any side effects they may
be having.

- Patient will complete 3 questionnaires about any symptoms they may have. The
questionnaires should take about 15-30 minutes to complete in total.

- Patient will perform hand function and balance tests. For these tests, patient will
complete tasks such as putting pegs into a pegboard. These tests should take about 20
minutes to complete.

Study Groups:

Patients 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):

Patient's acupuncture treatments will be given on an outpatient basis in private rooms. For
the treatment, patient 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 patient achieves 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, patient will receive acupuncture to the arms, legs, and
abdomen.

Study Visits:

One (1) time every week:

- Patient's vital signs will be measured.

- Patient will be asked about any drugs they may be taking and any side effects they may
be having.

At Weeks 3 and 6 (Group 1 only) and Weeks 2 and 4 (Group 2 only):

- Patient will complete the same 3 questionnaires they completed at baseline.

- Patient will perform hand function and balance tests.

Length of Study:

Patient may continue their participation on this study for up to 10 weeks, as long as the
study doctor thinks it is their best interest. Patient's active participation in this study
will be over after they have completed the 4-week follow-up visit.

Follow-Up:

Four (4) weeks after patient completes the acupuncture treatment, the following tests and/or
procedures will be performed:

- Patient's vital signs will be measured.

- Patient's medical history will be reviewed and any updates will be recorded.

- Patient will be asked about any drugs they may be taking and any side effects they may
be having.

- Patient will complete the same 3 questionnaires they completed at baseline.

- Patient 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.


Inclusion Criteria:



1. Patients must have the ability to understand English, sign a written informed consent
document, and be willing to follow protocol requirements.

2. Age >/= 18 years.

3. History of a diagnosis of breast cancer.

4. Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale
despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica.
Patients receiving any of these drugs must remain on the same medications throughout
the study period; however, adjustments in dosage are allowed. Patients will be
removed from the study if a change in type of medication is necessary. Patients are
allowed to stop medications but not replace them with other medications. New
medications for the treatment of CIPN are not allowed. All patients will receive
treatment to both upper and lower extremities, regardless of whether or not they are
experiencing symptoms in all four extremities.

5. The patient's previous chemotherapy treatment must have included a taxane
(paclitaxel, nab-paclitaxel, or docetaxel).

6. ECOG Performance Status of 0, 1, or 2.

7. If the patient is a woman of child-bearing potential, she must have a negative urine
pregnancy test and agree to use contraception.

8. Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments.

Exclusion Criteria:

1. Current active treatment with chemotherapy.

2. 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.)

3. Deformities that could interfere with accurate acupuncture point location.

4. Concurrent use of other alternative medicines such as herbal agents, high dose
vitamins and anticoagulation agents.

5. Known coagulopathy and 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 will be allowed to
participate.

6. Platelets < 50 H K/UL.

7. WBCs < 3.0 K/UL or ANC <1,500 K/UL)

8. Active 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.)

9. Cardiac pacemaker.

10. 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.)

11. Currently pregnant or lactating females. (Certain acupuncture applications have been
reported to stimulate uterine contractions and may alter lactation.)

12. History of diabetic neuropathy or neuropathy related to HIV.

13. Previous acupuncture treatment for any indication within 30 days of enrollment.

14. Active treatment for breast cancer.

15. Planned or actual changes in type of medications that could affect symptoms related
to PN.

16. Lymphedema considered severe by the treating clinician.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Score Changes in Neurotoxicity Scale

Outcome Description:

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.

Outcome Time Frame:

4 weeks and 6 weeks

Safety Issue:

No

Principal Investigator

Richard T. Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-1054

NCT ID:

NCT01815346

Start Date:

September 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast cancer survivors
  • Chronic, taxane-based chemotherapy-induced peripheral neuropathy
  • CIPN
  • Acupuncture treatments
  • Quality of life
  • Hand function
  • Balance
  • Questionnaires
  • Surveys
  • Breast Neoplasms
  • Peripheral Nervous System Diseases

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030