Acupuncture Chemotherapy-Induced Peripheral Neuropathy (CIPN) IRG

Breast Cancer Clinical Trial

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

Status Terminated

Clinical 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, balance, and the use of drugs for neuropathy pain.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases

• NCT number: NCT01815346
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 6, 2014
• Completion date: May 10, 2016