Using cryotherapy to prevent nerve damage from breast cancer chemotherapy
Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial
NA · Rigshospitalet, Denmark · NCT05928429
This study is testing whether using cold therapy during chemotherapy can help prevent nerve damage in women with early-stage breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05928429 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early-stage breast cancer receiving paclitaxel. Participants will be randomly assigned to either receive cryotherapy using Elasto-Gel™ gloves and socks during treatment or standard care. The study aims to evaluate the efficacy of this intervention and identify potential risk factors for developing CIPN. It is a multicenter, randomized, non-blinded trial involving 300 patients across various locations.
Who should consider this trial
Good fit: Ideal candidates are patients with early breast cancer scheduled to receive weekly paclitaxel treatment.
Not a fit: Patients with existing peripheral neuropathy or other significant limb conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of debilitating nerve damage in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of cryotherapy for CIPN is a novel approach, similar studies have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 or 12 doses, PS 0-1 Exclusion Criteria: Peripheral sensory/motor neuropathy, neuralgia or edema of the limb graded \>=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.
Where this trial is running
Copenhagen
- Maria E Lendorf — Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Maria E Lendorf, MD, PhD
- Email: maria.elisabeth.lendorf.02@regionh.dk
- Phone: +4526270898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer