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

NCT ID: NCT06400849

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2027-06-04

Brief 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.

Conditions

Non-metastatic Breast Cancer

Keywords

Non-metastatic breast cancer; Peripheral neuropathy; paclitaxel; cryotherapy; compression therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cryotherapy only

Single group, same patient, Homolateral wearing of cryotherapy devices only on hands and feet

Group Type: ACTIVE_COMPARATOR

cryotherapy alone of the upper or lower limbs

Intervention Type: DEVICE

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

Cryptherapy and compression

Single group, same patient, Homolateral wearing of cryotherapy and compression devices on hands and feet

Group Type: EXPERIMENTAL

cryotherapy and crompression of the upper or lower limbs

Intervention Type: DEVICE

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

Interventions

cryotherapy alone of the upper or lower limbs

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

Intervention Type: DEVICE

cryotherapy and crompression of the upper or lower limbs

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thuasne

INDUSTRY

Sponsor Role: collaborator

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Antoine Lacassagne

Nice, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Colin DEBAIGT, PhD

Role: primary

Clément DEVIC, PhD

Role: backup

Other Identifiers

2022/73

Identifier Type: -

Identifier Source: org_study_id