Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy

Trial Title: Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy

NCT ID: NCT06400849

Condition: Non-metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Non-metastatic breast cancer
Peripheral neuropathy
paclitaxel
cryotherapy
compression therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Intervention model description: Open-label, single-centre, randomised (1:1), stratified, self-controlled cohort study

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: cryotherapy alone of the upper or lower limbs
Description: Self-controlled trial with only standard cryotherapy. Compression glove and foot sock will only be worn on one hand and one leg on the same side allocated by randomisation
Arm group label: Cryotherapy only

Intervention type: Device
Intervention name: cryotherapy and crompression of the upper or lower limbs
Description: Self-controlled trial adding compression to standard cryotherapy. Compression glove and foot sock will only be worn on one hand and one leg on the same side allocated by randomisation
Arm group label: Cryptherapy and compression

Summary: 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, pain, altered temperature perception, myalgia, myopathy, fine motor difficulties, gait and balance disturbances, muscle weakness in the lower limbs and/or functional decline. NPIC occurs in 80 to 97% of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration. NPIC often leads to postponement or reduction of dose, or even discontinuation of treatment. In addition, NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae. This can promote and/or exacerbate symptoms of psychological distress (depressive symptoms and symptoms of anxiety) and lead to a reduction in quality of life (QoL). Prevention of NIPC is therefore a major issue in breast cancer treatment. According to the 2014 guidelines from the American Society of Clinical Oncology, prevention and treatment of IPN are inadequate with current weapons, and there is an urgent need to evaluate and find new methods of prevention. One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents. In recent years, the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves (SG) in preventing taxane-induced PINC has been reported. During chemotherapy, patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously. Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion. The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage, or mechanotransduction, and allow a reduction in NIPC. To date, no study has investigated the efficacy of combining the two means of prevention. The current standard at the Centre Antoine Lacassagne is cryotherapy. The aim of this prospective, self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer.

Criteria for eligibility:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Centre Antoine Lacassagne

Address:
City: Nice
Zip: 06189
Country: France

Status: Recruiting

Contact:
Last name: Colin DEBAIGT, PhD

Phone: + 33 4 92 03 17 78
Email: colin.debaigt@nice.unicancer.fr

Contact backup:
Last name: Clément DEVIC, PhD

Phone: + 33 4 92 03 15 11
Email: clement.devic@nice.unicancer.fr

Investigator:
Last name: Caroline BAILLEUX
Email: Principal Investigator

Start date: April 4, 2024

Completion date: June 4, 2027

Lead sponsor:
Agency: Centre Antoine Lacassagne
Agency class: Other

Collaborator:
Agency: Thuasne
Agency class: Industry

Source: Centre Antoine Lacassagne

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06400849