Acupuncture for CIPN in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Neuropathy; Sensation Disorders
• Interventions: Device: Acupuncture

• Registration Number: NCT02615678
• Lead Sponsor: Southern California University of Health Sciences

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-21
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life as measured by EORTC QLQ-30	At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
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)

Trial Locations

Locations (1)

Southern California University of Health Sciences; 🇺🇸 Whittier, California, United States