Acupuncture for CIPN in Breast Cancer Patients

NCT02615678 | Completed

• 1 other identifier: VINJ007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensation Disorders; Neuropathy

Keywords

neuropathy; peripheral; chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Acupuncture

EXPERIMENTAL

Acupuncture including scalp needling will be applied to selected points based on literature

Device: Acupuncture

Interventions

Acupuncture DEVICE

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

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum of 18 years of age
• Currently receiving neurotoxic chemotherapy
• Experiencing symptoms of chemotherapy induced neuropathy for at least 1 month
• Have a minimum score of 3 on the VAS should have a grade II CIPN on NCICTC
• Willing to sign an informed consent
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Southern California University of Health Sciences: lead

Study Sites (1)

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Sensation Disorders; Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sivarama Vinjamury, MD, MAOM

  Southern California University of Health Sciences, College of Eastern Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: November 26, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (1)