Acupuncture for CIPN in Breast Cancer Patients

NCT ID: NCT02615678

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Sensation Disorders Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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

Interventions

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Acupuncture

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Southern California University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sivarama Vinjamury

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sivarama Vinjamury, MD, MAOM

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences, College of Eastern Medicine

Locations

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Southern California University of Health Sciences

Whittier, California, United States

Site Status

Countries

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United States

Other Identifiers

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VINJ007

Identifier Type: -

Identifier Source: org_study_id

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