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Acupuncture for CIPN in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02615678
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, 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.

Condition or disease Intervention/treatment Phase
Sensation Disorders Neuropathy Device: Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series
Study Start Date : October 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture including scalp needling will be applied to selected points based on literature
Device: Acupuncture
Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615678


Locations
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United States, California
Southern California University of Health Sciences
Whittier, California, United States, 90604
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
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Principal Investigator: Sivarama Vinjamury, MD, MAOM Southern California University of Health Sciences, College of Eastern Medicine

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Responsible Party: Sivarama Vinjamury, Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT02615678     History of Changes
Other Study ID Numbers: VINJ007
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

Keywords provided by Sivarama Vinjamury, Southern California University of Health Sciences:
neuropathy
peripheral
chemotherapy
breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Sensation Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms