Acupuncture for CIPN in Breast Cancer Patients

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series

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

Study Overview

• Status: Completed
• Conditions: Sensation Disorders; Neuropathy
• Intervention / Treatment: Device: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Whittier, California, United States, 90604
      • Southern California University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; Acupuncture including scalp needling will be applied to selected points based on literature	Device: Acupuncture; Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perceived neuropathy as measured by EORTC CIPN-20	This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale.	At baseline, week 6 (treatment 12) and at week 10 (treatment 16)

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire	At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain	At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in quality of life as measured by EORTC QLQ-30	At baseline, week 6 (treatment 12) and at week 10 (treatment 16)

Collaborators and Investigators

• Sponsor: Southern California University of Health Sciences
• Investigators: Principal Investigator: Sivarama Vinjamury, MD, MAOM, Southern California University of Health Sciences, College of Eastern Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 21, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; neuropathy; peripheral
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders
• Other Study ID Numbers: VINJ007