Clinical trial · Observational
Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
NCT02549534CI-TRIAL-00030106completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: The purpose of the study is to test a new way of measuring nerve damage in women with breast cancer receiving chemotherapy drug paclitaxel (Taxol).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axon Flares | Procedure | — | UNRESOLVED |
| Axon Reflexes | Procedure | — | UNRESOLVED |
| Self-Reported Signs & Symptoms of CIPN | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Women with Breast Cancer (WBC)
- description
- Defined as women who: * Are 18 to 85 years old at the time of enrollment; * Have histologically-confirmed, first-time, non-metastatic breast cancer (Stage I-IIIB); * Have no history of neurotoxic chemotherapy or radiation treatment at the time of enrollment; * Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel), 80-100mg/m2, or bi-weekly (i.e., dose-dense) Taxol, 175 mg/m2, as a part of their treatment regimen OR * Will be receiving an anthracycline and cyclophosphamide (AC) therapy followed by weekly or bi-weekly (i.e., dose-dense; 175 mg/m2) paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2); * Are willing to participate in up to four study sessions.
- interventionNames
- Procedure: Axon Reflexes
- Procedure: Axon Flares
- Procedure: Self-Reported Signs & Symptoms of CIPN
- label
- Healthy Female Controls (HCs)
- description
- Defined as women who: * Are 18 to 85 years old at the time of study enrollment; * Can read, write, and understand English, * Are willing to participate in three planned study sessions.
- interventionNames
- Procedure: Axon Reflexes
- Procedure: Axon Flares
- Procedure: Self-Reported Signs & Symptoms of CIPN
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria for Women with Breast Cancer: * Age 18-85 * Able to read, write, and understand English * Diagnosed with histologically-confirmed, first-time, non-metastatic breast cancer (stage I-IIIB) * No prior exposure to neurotoxic chemotherapy or radiation at the time of enrollment, * Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel, 80- 100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen OR * Will be receiving an anthracycline and cyclophosphamide (AC) followed by weekly paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen; Inclusion Criteria for Healthy Controls: * Aged 18-85 * Can read, write, and understand English Exclusion Criteria: * A history of cardiovascular disease, hypertension, or peripheral arterial/vascular disease; * Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, Phosphodiesterase-5 (PGE5) inhibitors) or (2) the use of statins for cholesterol; * Suspected or diagnosed diabetes (with the exception of gestational diabetes); * Pre-existing neuropathy, neuropathic pain, or nerve injury; * Pain or significant arthritis in the toes of either foot; * Current skin disease or fungal infection of the feet; * Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings; * Diagnosed or suspected vasospastic disease such as Raynaud's syndrome; * Current use of tobacco/tobacco-containing products; * Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected. In-Study Restrictions: * No caffeine- or alcohol-containing products for 12 hours prior to their study visit; * No food for at least one hour prior to blood flow monitoring; * No non-steroidal anti-inflammatory drugs (NSAIDS) for 24 hours prior to study visits unless directed by a physician to do so. (Note: These restrictions are designed to improve the rigor and quality of the data, but non-compliance will not be grounds for study exclusion; adherence to these restrictions will be monitored during self-report).
References
Publications (116)
- BACKGROUNDGolan-Vered Y, Pud D. Chemotherapy-induced neuropathic pain and its relation to cluster symptoms in breast cancer patients treated with paclitaxel. Pain Pract. 2013 Jan;13(1):46-52. doi: 10.1111/j.1533-2500.2012.00554.x. Epub 2012 Apr 26. PMID 22533683
- BACKGROUNDHershman DL, Weimer LH, Wang A, Kranwinkel G, Brafman L, Fuentes D, Awad D, Crew KD. Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat. 2011 Feb;125(3):767-74. doi: 10.1007/s10549-010-1278-0. Epub 2010 Dec 3. PMID 21128110
- BACKGROUNDWolf SL, Barton DL, Qin R, Wos EJ, Sloan JA, Liu H, Aaronson NK, Satele DV, Mattar BI, Green NB, Loprinzi CL. The relationship between numbness, tingling, and shooting/burning pain in patients with chemotherapy-induced peripheral neuropathy (CIPN) as measured by the EORTC QLQ-CIPN20 instrument, N06CA. Support Care Cancer. 2012 Mar;20(3):625-32. doi: 10.1007/s00520-011-1141-9. Epub 2011 Apr 12. PMID 21479990
- BACKGROUNDForsyth PA, Balmaceda C, Peterson K, Seidman AD, Brasher P, DeAngelis LM. Prospective study of paclitaxel-induced peripheral neuropathy with quantitative sensory testing. J Neurooncol. 1997 Oct;35(1):47-53. doi: 10.1023/a:1005805907311. PMID 9266440
- BACKGROUNDO'Shaughnessy J, Gradishar WJ, Bhar P, Iglesias J. Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis. Breast Cancer Res Treat. 2013 Apr;138(3):829-37. doi: 10.1007/s10549-013-2447-8. Epub 2013 Apr 6. PMID 23563958
- BACKGROUNDPark SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC. Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204. PMID 24590861