Using cryotherapy and compression to prevent neuropathy in breast cancer patients
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing the Development of Paclitaxel-induced Peripheral Neuropathy in Non-metastatic Breast Cancer: A Prospective, Single-centre, Self-controlled Trial
This study is testing if using cold therapy and compression can help prevent nerve damage in women with breast cancer who are getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Centre Antoine Lacassagne Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Nice) |
| Trial ID | NCT06400849 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining cryotherapy with compression therapy to prevent chemotherapy-induced peripheral neuropathy (CIPN) in women undergoing treatment for non-metastatic breast cancer. Patients aged 18 and older with localized or locally advanced breast cancer will receive 3 to 4 cycles of paclitaxel, with some also receiving trastuzumab, pertuzumab, carboplatin, or endoxan. The study aims to assess whether these interventions can reduce the incidence and severity of neuropathy symptoms associated with taxane chemotherapy. Participants will be monitored for changes in their peripheral nerve function throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with localized or locally advanced breast cancer who are scheduled to receive paclitaxel chemotherapy.
Not a fit: Patients with metastatic breast cancer or those experiencing significant pre-existing peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for breast cancer patients by reducing the risk of debilitating neuropathy.
How similar studies have performed: While similar approaches have been explored, this specific combination of cryotherapy and compression therapy for CIPN prevention in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age ≥ 18 years ; * Performance Status (PS): 0 to 2 * Women with localised or locally advanced breast cancer of any histology * Indication for treatment with 3 to 4 cycles of paclitaxel (+/- trastuzumab, pertuzumab, carboplatin or endoxan) as adjuvant or neoadjuvant therapy. The choice of the number of cycles will be at the investigator's discretion. * Symmetry of upper limb peripheral neuropathy grade ≤ 1 according to CTCAE version 5.0 at inclusion. * Presence of radial pulses in the upper limbs. * Presence of tibio-posterior and tibio-anterior ankle pulses or ankle systolic pressure index \> 0.9. * Patient has read the information note and signed the informed consent form. * The patient is covered by social security. Exclusion Criteria: * Patient age \< 18 years * Patients diagnosed with metastatic or bilateral breast cancer * Patients with metastatic disease of any location * Peripheral neuropathy grade ≥ 2 according to CTCAE version 5.0 of the upper or lower limbs * Patients with asymmetric upper limb peripheral neuropathy grade \> 1 according to CTCAE version 5.0 at inclusion. \*In the case of asymmetry of the lower limbs of grade \> 1 according to CTCAE version 5.0, the patient will not be considered a failure in selection but the corresponding secondary criteria will not be analysed. * Patients with underlying medical conditions that could potentially cause peripheral neuropathy (diabetes mellitus, chronic alcoholism, unilateral lymphoedema or postherpetic neuralgia), or any other reason based on the investigator's judgement. * Diagnosed Raynaud's syndrome * Obstructive arterial disease of the lower limbs * History of myocardial infarction * Patients already using compression foot socks * Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017: * Pregnant women * Incapacitated participants who have not given their free and informed consent or refused to do so before the onset of their incapacity, who do not fall under the provisions of Article 64 ; * Pregnant or breast-feeding women who are not covered by the provisions of article 66; * Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.
Where this trial is running
Nice
- Centre Antoine Lacassagne — Nice, France (Recruiting)
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.