Breast Cancer, Peripheral Neuropathy
Conditions
Keywords
Acupuncture, Paclitaxel, 15-011
Brief summary
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.
Interventions
PROCEDUREAcupuncture
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.
BEHAVIORALNeuropathic Pain Scale (NPS) questionnaire
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.
BEHAVIORALFACT/GOG-Ntx questionnaire
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Screening Phase: * Age 21 or older. * Histologically proven stage I-III carcinoma of the breast. * Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel. * Eastern Cooperative Oncology Group performance status 0-2 (see Appendix B). * The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. * Proficiency in English with the ability to speak and read English.
Exclusion criteria
* Known metastatic (stage IV) breast cancer involvement. * Pre-existing peripheral neuropathy within 28 days of screening consent * Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine. Intervention Phase: * Age 21 or older. * Histologically proven stage I-III carcinoma of the breast. * Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane. * Eastern Cooperative Oncology Group performance status 0-2 * The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. * Proficiency in English with the ability to speak and read English * While on neurotoxic chemotherapy, has developed NCI-CTC grade 2 CIPN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0 | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIPN severity as measured by FACT/GOG-Nts | 2 years | 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 . |
Countries
United States
Outcome results
None listed