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Acupuncture for CIPN in Breast Cancer Patients

Primary Purpose

Sensation Disorders, Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensation Disorders focused on measuring neuropathy, peripheral, chemotherapy, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Southern California University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire
Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain
Changes in quality of life as measured by EORTC QLQ-30

Full Information

First Posted
November 21, 2015
Last Updated
May 14, 2019
Sponsor
Southern California University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02615678
Brief Title
Acupuncture for CIPN in Breast Cancer Patients
Official Title
Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensation Disorders, Neuropathy
Keywords
neuropathy, peripheral, chemotherapy, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture including scalp needling will be applied to selected points based on literature
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.
Primary Outcome Measure Information:
Title
Changes in perceived neuropathy as measured by EORTC CIPN-20
Description
This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale.
Time Frame
At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Secondary Outcome Measure Information:
Title
Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire
Time Frame
At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Title
Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain
Time Frame
At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Title
Changes in quality of life as measured by EORTC QLQ-30
Time Frame
At baseline, week 6 (treatment 12) and at week 10 (treatment 16)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivarama Vinjamury, MD, MAOM
Organizational Affiliation
Southern California University of Health Sciences, College of Eastern Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Acupuncture for CIPN in Breast Cancer Patients

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