Clinical trial NCT02615678: Acupuncture for CIPN in Breast Cancer Patients
Official title: Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensation Disorders
Neuropathy
Keywords: neuropathy
peripheral
chemotherapy
breast cancer
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.

Detailed description: Ideally 10 patients experiencing peripheral neuropathy due to chemotherapy from breast cancer treatment will be included in this study.They will receive 16 total acupuncture treatments over 10 weeks including various points based off of research and classical text and scalp acupuncture.

Eligibility criteria: Inclusion criteria:

1. Minimum of 18 years of age
2. Currently receiving neurotoxic chemotherapy
3. Experiencing symptoms of chemotherapy induced neuropathy for at least 1 month
4. Have a minimum score of 3 on the VAS should have a grade II CIPN on NCICTC
5. Willing to sign an informed consent
6. Stable treatment for more than two months before screening

   * Stable treatment is defined as no change in the type and dose of medications 2 months prior to enrollment.
   * Once enrolled, the patients will be asked to remain on the same type and dose of the medications for neuropathy

Exclusion Criteria:

1. Receiving any treatment to prevent neuropathy 2 weeks prior to the screening
2. Pre-existing peripheral neuropathy due to any other cause than chemotherapy
3. Pre-existing conditions like pregnancy, uncontrolled diabetes, hypertension, cardiovascular disorders, bleeding disorders, depression (BDI \> 21)
4. Unwilling to follow the protocol
5. Individuals who are receiving government disability assistance

Primary outcomes:
measure: Changes in perceived neuropathy as measured by EORTC CIPN-20
timeFrame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Secondary outcomes:
measure: Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire
timeFrame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
measure: Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain
timeFrame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
measure: Changes in quality of life as measured by EORTC QLQ-30
timeFrame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences, College of Eastern Medicine
name: Sivarama Vinjamury, MD, MAOM
role: PRINCIPAL_INVESTIGATOR
References: