Clinical trial NCT02364726: Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients
Official title: Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Peripheral Neuropathy
Keywords: Acupuncture
Paclitaxel
15-011
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0
timeFrame: 1 year
Secondary outcomes:
measure: CIPN severity as measured by FACT/GOG-Nts
timeFrame: 2 years
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ting Bao, MD, DABMA, MS
role: PRINCIPAL_INVESTIGATOR
References: