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Clinical Trials/NCT02615678
NCT02615678
Completed
Not Applicable

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

Southern California University of Health Sciences1 site in 1 country10 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensation Disorders
Sponsor
Southern California University of Health Sciences
Enrollment
10
Locations
1
Primary Endpoint
Changes in perceived neuropathy as measured by EORTC CIPN-20
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sivarama Vinjamury

Professor

Southern California University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Changes in perceived neuropathy as measured by EORTC CIPN-20

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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