Acupuncture for CIPN in Breast Cancer Patients

Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615678
• Other study ID #: VINJ007
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neuropathy
• Sensation Disorders

Intervention

Device:
• Acupuncture
Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.

Locations

Country	Name	City	State
United States	Southern California University of Health Sciences	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain		At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Secondary	Changes in quality of life as measured by EORTC QLQ-30		At baseline, week 6 (treatment 12) and at week 10 (treatment 16)