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OpenTrials
Completed

NCT Number: NCT02615678

Acupuncture for CIPN in Breast Cancer Patients

The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.

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Key information

Conditions

Sensation Disorders Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuropathy Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Southern California University of Health Sciences

Whittier, California, 90604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2015
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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