Houston, Texas 77030


Purpose:

The goal of this clinical research study is to compare 3 types of interventions (involving electro-acupuncture and standard care) that are given to women with chronic post-surgical pain after a mastectomy. Researchers want to find out which intervention may be most effective in relieving breast pain. The safety of these 3 interventions will also be studied. This is an investigational study. Acupuncture needles are an FDA approved medical device, but acupuncture therapy itself is considered investigational. Up to 109 participants will be enrolled in this study. All will take part at MD Anderson.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02754752


Primary Contact:

Principal Investigator
Kay Garcia, DRPH
M.D. Anderson Cancer Center

Kay Garcia, DRPH
Phone: 713-563-7413
Email: lcohen@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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