Clinical trial · Interventional
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
NCT01243541CI-TRIAL-00040160terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI decision due to low accrual and lack of funding
Summary
Brief summary (as posted)
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| cryotherapy | Procedure | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.
- interventionNames
- Procedure: cryotherapy
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Procedure: management of therapy complications
- Procedure: assessment of therapy complications
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically confirmed diagnosis of breast cancer (any stage) * Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy * Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals * Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation * Prior chemotherapies are permitted, except with prior treatments with taxanes * Required lab values: CBC, Comprehensive Chemistry Panel * Desired lab values: If the patient's record also includes TSH, HbA1c, and folate, then those will be recorded as well * All patients will have given signed, informed consent prior to registration Exclusion Criteria: * Patients must not have received any prior taxane treatments * Patients must not have a history of peripheral neuropathy (regardless of cause) * Patient must not have a history of diabetes mellitus * Patient must not have a history of Raynaud's disease * Men are not eligible
References
Publications (0)
Data not yet available
No reference posted for this study.