Randomized-Controlled Trial of Acupuncture for Chronic Pain after Breast Cancer Treatment
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.
Disease Group: Malignant neoplasm of breast
Treatment Agent: Acupuncture
Treatment Location: Only at MDACC
Sponsor: Gateway for Cancer Research
Primary Aim 1: Determine the initial efficacy of EA in reducing chronic pain in women following treatment for breast cancer. Our primary hypothesis is: 1) Participants who receive EA will have significantly greater improvement in chronic pain than those in a WLC group. Our secondary hypotheses are: 2) Participants who receive EA will have significantly greater improvement in chronic pain than those who receive SEA and 3) Participants in SEA will report better improvement in pain than those in WLC group. Secondary Aims: Aim 2: Determine if EA produces greater improvement in physical functional mobility as compared to SEA or WLCs. Our hypothesis is: Participants with chronic pain due to post-mastectomy pain syndrome (PMPS) who receive EA will have greater improvement in functional mobility of the ipsilateral shoulder, arm and hand than those who receive SEA or WLCs. Aim 3: Determine if EA produces greater improvement in overall quality of life (QOL) and symptoms related to fatigue, sleep and mood disturbance compared to SEA or WLC. Our hypothesis is: Participants who receive EA will have greater improvement in overall QOL and symptoms related to fatigue, sleep and mood than those who receive SEA or WLC. Aim 4: Determine if EA produces lower pain vigilance and awareness as compared to SEA or WLC. Our hypothesis is: Participants who receive EA will have lower pain vigilance/awareness scores than those who receive SEA or WLC. Aim 5: Examine the association between baseline expectancy and outcomes. Our hypotheses are that expectancy will moderate response to EA/SEA such that: 1) Participants who receive SEA and have high expectancy at baseline will have significantly greater improvement outcomes than those who receive SEA and have a low expectancy at baseline, and 2) Expectancy at baseline will not be associated with outcomes for those who receive EA. Aim 6: Explore associations between response to acupuncture and biologic measures, including 1) single nucleotide polymorphisms (SNPS) in catechol-O- methyltransferase (COMT) and opioid receptor-mu1 (OPRM1), and 2) ATX/LPA axis. Our hypotheses are: Participants who respond positively to electroacupuncture will exhibit 1) different gene variations in COMT and OPRM1, and 2) greater inhibition of ATX-mediated LPA biosynthesis than those who do not respond positively to electroacupuncture. Aim 7: Explore if EA reduces emotional, financial, and behavioral concerns among patients and caregivers compared to the SEA or WLC. Our hypothesis is: Participants who receive EA and their caregivers will report less burden and greater behavioral support than those who do not receive EA.
IRB Review and Approval Date: 09/13/2016
Recruitment Status: Open
Projected Accrual: N/A
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.
1) Metastatic breast cancer (stage IV).
2) Known bleeding disorder per patient reported history.
3) Cardiac pacemaker or other implanted electronic devices.
4) Current lymphedema treatment.
5) Currently receiving acupuncture for any condition or if they have ever used acupuncture before.
Information and next steps
Malignant neoplasm of breast
Palliative Care and Rehabilitation Medicine
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