💬In plain words
What the trial is, and whether it could suit you
Breast cancer is the most frequently diagnosed cancer in the world. In France, 58,000 new cases were detected in 2018. Breast cancer is therefore the most common cancer in women. The 5-year survival rate for all stages combined is 88%. These excellent survival figures have been achieved thanks to improvements in treatment, including the advent of chemotherapy. The majority of patients will be cured of their cancer, so post-cancer quality of life is a major issue, hence the importance of trying to reduce long-term sequelae.
Taxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer. However, taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy (CIPN). The mechanisms of NPIC by taxanes are not fully understood. CINP is manifested by symptoms of paresthesia, numbness, burning
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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