Trial of Acupuncture for Chronic Pain After Breast Cancer Treatment

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) into 1 of 3 groups. This is done because no one knows if one study group
is better, the same, or worse than the other group. You have an equal chance of being
assigned to each group.

- Group 1 will receive up to 10 electro-acupuncture sessions over 4 weeks.
Electro-acupuncture is a technique that seeks to treat symptoms by inserting very thin,
solid, sterile, stainless steel needles into the skin at specific points.

- Group 2 will receive up tp 10 electro-acupuncture sessions over 4 weeks using slightly
different techniques by placing needles at different points on the body than those used
for Group 1. The acupuncture points used in Group 2 may not be as effective as those
used in Group 1.

- Group 3 will receive standard care without any kind of acupuncture during the study
period.

If you are assigned to receive electro-acupuncture, you will not know if you are assigned to
Group 1 or 2.

The acupuncture needles are small, solid, stainless steel needles that come in sterile single
packages. A mild electrical current (electro-acupuncture) may be applied to the needles at a
level that is comfortable for you.

Study Therapy:

Participants in Groups 1 and 2 will receive a total of up to 10 electro-acupuncture sessions.
About 2-3 sessions will be given each week for 4 weeks. Each electro-acupuncture session will
take about 45 minutes to complete.

Group 3 will be treated with standard care for post-surgical pain after a mastectomy.

Study Visits:

During Weeks 1-3, you will be asked to complete a questionnaire about your level of pain.
This will take about 5 minutes to complete.

At the Week 4 visit, the following procedures will take place:

- You will have a physical exam.

- You will complete the screening questionnaires.

- Blood (about 4 teaspoons) will be drawn for tests to measure biomarkers, including
genetic biomarkers.

If you are not able to complete the questionnaires during your regularly-scheduled visits,
you will be able to take the questionnaires home to complete them or they will be mailed to
you (if you are in Group 3). You will be given a postage-paid return envelope to mail them
back to the study doctor.

About 1 month later, at Week 8, you will repeat the following procedures:

- You will have a physical exam.

- You will complete the screening questionnaires.

Length of Study:

You will remain on study for up to 8 weeks. You may be taken off study early if your doctor
thinks it is in your best interest or if you are unable to follow study instructions (such as
keeping appointments or completing questionnaires).

Follow-up Acupuncture Therapy:

After your 8 weeks of study participation are over, if you were assigned to the wait list
group or acupuncture group believed to be less effective (G2), you will be offered up to 10
sessions of the other acupuncture treatment in the 4 weeks following your study
participation. These acupuncture treatments will be performed at no cost to you.

Inclusion Criteria:

1. Be adult women >/= 18 years of age.

2. Be able to read, write, and speak English.

3. Able to give informed consent.

4. Have a history of stage I, II, or III breast cancer

5. Have a documented visit with an oncologist during the previous 6-months.

6. Have no current evidence of disease.

7. Have persistent pain (unrelated to aromatase inhibitors or chemotherapy-induced
peripheral neuropathy) for at least 3 months following treatment for breast cancer.

8. Have pain severity (arithmetic mean of four pain severity items) >/= 2 on BPI.

9. Have worst pain >/= to 4 (0-10 NRS) in the preceding week.

10. Be willing and able to adhere to all study-related procedures.

11. Have completed all cancer treatment (including surgery, chemotherapy and/or radiation)
at least 4 months prior to enrollment.

12. Have documented labwork with absolute neutrophil count (ANC) >/= 1.0 K/uL and
platelets >/= 50K/uL in the past 12 months.

13. If applicable, maintain self-management of lymphedema symptoms being performed at home
at time of study entry.

Exclusion Criteria:

1. Metastatic breast cancer (stage IV).

2. Known bleeding disorder per patient reported history.

3. Cardiac pacemaker or other implanted electronic devices.

4. New or planned new lymphedema treatment during the study period

5. Currently receiving acupuncture for any condition or if they have ever used
acupuncture before.