N/A
N=23
Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Anatomic Stage IB Breast Cancer AJCC v8 · Anatomic Stage II Breast Cancer AJCC v8 · Anatomic Stage IIA Breast Cancer AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT03505671 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) — 16.7; 17.5; 13.7; 14.8 score on a scale — p=0.61
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture Therapy (Procedure); Best Practice (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) |
16.7; 17.5; 13.7; 14.8; -2.9; -2.5 | 0.61 |
| SECONDARY Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 |
11.1; 11.3; 11.0; 11.1; 0.1; -0.1 | 0.91 |
| SECONDARY Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling |
4; 2; 3; 8; 2; 1 | 0.41 |
| SECONDARY CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling |
10; 10; 1; 2; 0; 0 | 0.99 |
| SECONDARY Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy |
6; 7; 3; 3 | 0.99 |
| SECONDARY Number of Cycles of Completed Chemotherapy |
4.4; 4.2 | 0.69 |
| SECONDARY Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) |
3.1; 2.8; 14.2; 12.7; 3.0; 3.0 | 0.46 |
| SECONDARY Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) |
9.5; 9.5; 8.8; 10.9; -1.5; 0.7 | 0.20 |
| SECONDARY Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) |
3.4; 3.4; 3.4; 3.3; 0.0; 0.0 | 0.81 |
| SECONDARY Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) |
51.1; 45.9; 50.5; 48.7; -1.0; 2.2 | 0.98 |
| SECONDARY Nerve Fiber Density in the Skin |
7.8; 8.3; 3.5; 4.3; -5.1; -4.5 | — |
Summary
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
Eligibility Criteria
Inclusion Criteria
- Breast and GI cancer stage I-III
- Currently receiving or recently completed neurotoxic chemotherapy (either adjuvant or neoadjuvant). Currently is defined as including up until when the next cycle would be delivered, that is if the patient is getting chemotherapy every week, this would include a week after their last treatment; if the patient is getting treatment every 2 weeks, this would include 2 weeks after their last treatment; if the patient is getting treatment every 3 weeks, this would include 3 weeks after their last treatment, etc. Recently completed is defined as 6 weeks after this time period. For example, if a patient was getting chemotherapy every week, this would include seven weeks after their last treatment; if the patient was getting treatment every 2 weeks, this would include 8 weeks after their last treatment; if the patient were getting treatment every 3 weeks, this would include 9 weeks after their last treatment, etc.
- Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAE
- Ability and willingness to understand and sign an informed consent
Exclusion Criteria
- Self-reported or documented history of UNRESOLVED pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions.
- Unable to provide medical history.
- Male patients.
- Pregnant.
- Unwilling to receive acupuncture or unable to travel for treatments.
Data sourced from ClinicalTrials.gov (NCT03505671). 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.