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.