N/A
N=20
Acupuncture on Chemotherapy-induced Peripheral Neuropathy
Randomized Controlled Trial · Breast Cancer · Chemotherapy-induced Peripheral Neuropathy · Acupuncture
Bottom Line
View on ClinicalTrials.gov: NCT03626220 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF) — 3.10; 3.10; 1.72; 3.50 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acupuncture (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- China Medical University Hospital
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF) |
3.10; 3.10; 1.72; 3.50; 1.63; 2.78 | — |
| SECONDARY Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13 |
37.60; 33.90; 37.89; 33.62; 41.00; 36.44 | — |
| SECONDARY World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version) |
60.80; 55.20; 60.88; 59.50; 3.63; 4.30 | — |
| SECONDARY Touch Test Sensory Evaluator |
1.64; 1.62; 0.41; 1.82; -1.54; 0.20 | — |
Summary
Peripheral neuropathy is currently the second most common side effect after chemotherapy, second only to the side effects of blood toxicity. A variety of chemotherapy drugs may induce peripheral neurotoxicity and cause by the cumulative dose of chemotherapy drugs. Symptoms include sensory paresthesia, feeling dullness or numbness, glove-like feeling distributed in the palm. The currently most effective way is to interrupt the treatment or adjust the dose of chemotherapeutic drugs, but it is easy to make patients discontinue chemotherapy. The purpose of this study is to explore the impact of acupuncture on neurological symptoms and quality of life. Three kinds of questionnaires will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13 (Version 4) to assess changes in neurological symptoms; (3) World Health Organization Quality of Life Scale-(WHOQOL-BREF) to assess changes in the quality of life of patients. The course of treatment was evaluated for nine weeks. Changes in neurological function and quality of life will be evaluated before treatment, the third week of treatment, the sixth week of treatment, till the ninth week. The aim of this study is to confirm that acupuncture can improve peripheral neuropathy after chemotherapy, in order to enhance breast cancer patients' quality of life, and provide the new opportunity for integrative therapy between Chinese and Western medicine.
Keywords：acupuncture , chemotherapy-induced peripheral neuropathy
Eligibility Criteria
The inclusion criteria will be: female more than 20 years of age; breast cancer with early stage at I-III; had completed chemotherapy; the neurotoxic chemotherapeutic agents included taxanes, platinums, or others; less than grade three in the Eastern Cooperative Oncology Group (ECOG) status; higher than grade one in National Cancer Institute-common terminology criteria for adverse events(NCI-CTCAE) scale.
The exclusion criteria will be: having less than three months in mean survival time, history of diabetic neuropathy before chemotherapy administration, history of other preexisting peripheral neuropathy, other inflammatory or metabolic arthritis, severe blood coagulation diseases or with latent bleeding tendency, unstable cardiovascular diseases, or other preexisting muscle-skeletal diseases.
Data sourced from ClinicalTrials.gov (NCT03626220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.