Neuropathy, Sensation Disorders
Conditions
Keywords
neuropathy, peripheral, chemotherapy, breast cancer
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.
Interventions
DEVICEAcupuncture
Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.
Sponsors
Southern California University of Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in perceived neuropathy as measured by EORTC CIPN-20 | 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
| Measure | Time frame |
|---|---|
| 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) |
| Changes in quality of life as measured by EORTC QLQ-30 | At baseline, week 6 (treatment 12) and at week 10 (treatment 16) |
Countries
United States
Outcome results
None listed