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The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.
Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study the investigators will assess if acupuncture can be used to ease the pain, tingling and numbness that may be caused by chemotherapy and improve quality of life during chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | As part of routine clinical care, a chemotherapy nurse, research nurse, or physician will assess the patient's symptoms including CIPN based on the NCI-CTC 4.0 criteria to determine the grade of CIPN. Once these patients develop National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for the intervention phase of the study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients who consent to the intervention phase of the study will then be treated with weekly acupuncture until the end of chemotherapy. No concomitant anti-neuropathy medication will be permitted. Subjects will receive acupuncture in bilateral ear points: shen men, point zero, two additional auricular acupuncture point where electrodermal signal is detected and bilateral body acupuncture points: LI4, TE5, LI11, ST40, Ba Feng, Ba xie. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK. |
| Measure | Description | Time Frame |
|---|---|---|
| CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0 | After the initiation of acupuncture through the end of chemotherapy in breast cancer patients undergoing neoadjuvant or adjuvant weekly paclitaxel chemotherapy when compared to historical control ECOG study 1199 [1] weekly paclitaxel treatment arm. The efficacy of acupuncture in reducing CIPN severity and preventing progression of grade 2 CIPN to grade 3 or higher. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CIPN severity as measured by FACT/GOG-Nts | Validated patient-reported outcome questionnaires: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire, the Neuropathy Pain Scale (NPS) and the vibration sensation test will be assessed at the time of intervention consent and then after the last acupuncture session on the same day of the last chemotherapy. CIPN grade per NCI-CTC 4.0 will be assessed weekly and then once again at 3 months (+/-2 weeks) after chemotherapy completion . |
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Inclusion Criteria:
Screening Phase:
Exclusion Criteria:
Intervention Phase:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Bao, MD, DABMA, MS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States | ||
| Memorial Sloan Kettering Cancer Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2016 | Jul 8, 2020 |
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| Neuropathic Pain Scale (NPS) questionnaire | Behavioral | It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session. |
|
| FACT/GOG-Ntx questionnaire | Behavioral | It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion. |
|
| 2 years |
| New York |
| New York |
| 10065 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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