Non-metastatic Breast CancerARIANENCT06400849
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy
A study testing cryotherapy alone of the upper or lower limbs and cryotherapy and crompression of the upper or lower limbs in people with Non-metastatic Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Non-metastatic Breast Cancer
- What is being tested?
- cryotherapy alone of the upper or lower limbs and cryotherapy and crompression of the upper or lower limbs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to 4 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Colin DEBAIGT, PhD, + 33 4 92 03 17 78, colin.debaigt@nice.unicancer.fr
Clément DEVIC, PhD, + 33 4 92 03 15 11, clement.devic@nice.unicancer.fr
About this study
Official title: 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
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.
Read more
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
- Being tested
- cryotherapy alone of the upper or lower limbs, cryotherapy and crompression of the upper or lower limbs
- Keywords
- Non-metastatic breast cancer, Peripheral neuropathy, paclitaxel, cryotherapy, compression therapy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy alone of the upper or lower limbsDevice
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
cryotherapy and crompression of the upper or lower limbsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy only | Active comparator | Single group, same patient, Homolateral wearing of cryotherapy devices only on hands and feet Receives: Device: cryotherapy alone of the upper or lower limbs |
| Cryptherapy and compression | Experimental | Single group, same patient, Homolateral wearing of cryotherapy and compression devices on hands and feet Receives: Device: cryotherapy and crompression of the upper or lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy in preventing peripheral neuropathy as determined by medical staff between cryotherapy treatment alone and combined cryotherapy and compression treatment of the upper limbs in patients treated with paclitaxel.
The limb with the highest grade of neuropathy will be given a score of 1 and the limb with the lowest grade of neuropathy a score of 0. If no neuropathy is identified in either of the 2 limbs, a score of 0 will be given for each limb. Finally, if a neuropathy of the same grade is identified in each of the 2 limbs, a score of 1 will be assigned for both limbs.
Success is defined as a differential of -1 in neuropathy score in favour of double prevention. This method will be applied to the primary and secondary endpoints.
Measured: 7 days after completion of C3D15 or C4D1 if applicable (each cycle is 21 days)
Secondary outcomes (6)
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the upper limbs in reducing the occurrence of peripheral neuropathy as determined by medical staff throughout the course of treatment.
Differential between the two upper limbs
Measured: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1) (each cycle is 21 days), at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the lower limbs in reducing the occurrence of peripheral neuropathy as determined by medical staff throughout the course of treatment.
Differential between the two upper limbs
Measured: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1 and 7 days after C3D15 or C4D1 if applicable), (each cycle is 21 days) at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the lower limbs in reducing the occurrence of peripheral neuropathy as determined by the patient throughout the course of treatment.
Differential between the two lower limbs
Measured: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1 and 7 days after C3D15 or C4D1 if applicable) (each cycle is 21 days), at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
Comparing cryotherapy tolerance rates with and without compression
Rate of discontinuation of cryotherapy during treatment
Measured: During D1, D8 and D15 of all cycles ((each cycle is 21 days)
Evaluate the impact of compression on the temperature at the extremities
Comparison of the temperature measured between the upper and lower limbs (at extremity level) using an infrared thermometer
Measured: 15 minutes before and after removal of cryotherapy and compression devices at D1, D8 and D15 of each chemotherapy cycle (each cycle is 21 days)
Study the percentage and characteristics of peripheral neuropathy according to the DN4 questionnaire during treatment
Percentage of patients with peripheral neuropathy for any limb according to the results of the DN4 questionnaire just before each treatment cycle
Measured: C1D1, C2D1, C3D1 and 7 days after C3D15), (each cycle is 21 days) at 1 month (±2 weeks) and 4 months after the end of chemotherapy (±2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start4 Apr 2024
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open-label, single-centre, randomised (1:1), stratified, self-controlled cohort study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Collaborators
- Thuasne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400849
- Sponsor's protocol ID
- 2022/73
- Acronym
- ARIANE
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06400849
- Acronym / sponsor ID
- ARIANE / 2022/73
- Conditions
- Non-metastatic Breast Cancer
- Keywords
- Non-metastatic breast cancer, Peripheral neuropathy, paclitaxel, cryotherapy, compression therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Collaborators
- Thuasne
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, single-centre, randomised (1:1), stratified, self-controlled cohort study
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy only | Active comparator | Device: cryotherapy alone of the upper or lower limbsSingle group, same patient, Homolateral wearing of cryotherapy devices only on hands and feet |
| Cryptherapy and compression | Experimental | Device: cryotherapy and crompression of the upper or lower limbsSingle group, same patient, Homolateral wearing of cryotherapy and compression devices on hands and feet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapy alone of the upper or lower limbsSelf-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 | Device | Cryotherapy only |
| cryotherapy and crompression of the upper or lower limbsSelf-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 | Device | Cryptherapy and compression |
Primary outcome
To compare the efficacy in preventing peripheral neuropathy as determined by medical staff between cryotherapy treatment alone and combined cryotherapy and compression treatment of the upper limbs in patients treated with paclitaxel.
Time frame: 7 days after completion of C3D15 or C4D1 if applicable (each cycle is 21 days)
The limb with the highest grade of neuropathy will be given a score of 1 and the limb with the lowest grade of neuropathy a score of 0. If no neuropathy is identified in either of the 2 limbs, a score of 0 will be given for each limb. Finally, if a neuropathy of the same grade is identified in each of the 2 limbs, a score of 1 will be assigned for both limbs. Success is defined as a differential of -1 in neuropathy score in favour of double prevention. This method will be applied to the primary and secondary endpoints.
6 secondary outcomes
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the upper limbs in reducing the occurrence of peripheral neuropathy as determined by medical staff throughout the course of treatment.
Time frame: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1) (each cycle is 21 days), at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the lower limbs in reducing the occurrence of peripheral neuropathy as determined by medical staff throughout the course of treatment.
Time frame: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1 and 7 days after C3D15 or C4D1 if applicable), (each cycle is 21 days) at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
To compare the efficacy of cryotherapy alone and combined cryotherapy and compression treatment of the lower limbs in reducing the occurrence of peripheral neuropathy as determined by the patient throughout the course of treatment.
Time frame: At inclusion, just before each treatment cycle (C1D1, C2D1, C3D1 and 7 days after C3D15 or C4D1 if applicable) (each cycle is 21 days), at 1 month (±2 weeks) and at 4 months after the end of chemotherapy (±2 weeks)
Comparing cryotherapy tolerance rates with and without compression
Time frame: During D1, D8 and D15 of all cycles ((each cycle is 21 days)
Evaluate the impact of compression on the temperature at the extremities
Time frame: 15 minutes before and after removal of cryotherapy and compression devices at D1, D8 and D15 of each chemotherapy cycle (each cycle is 21 days)
Study the percentage and characteristics of peripheral neuropathy according to the DN4 questionnaire during treatment
Time frame: C1D1, C2D1, C3D1 and 7 days after C3D15), (each cycle is 21 days) at 1 month (±2 weeks) and 4 months after the end of chemotherapy (±2 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy alone of the upper or lower limbs and cryotherapy and crompression of the upper or lower limbs in people with Non-metastatic Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy in preventing peripheral neuropathy as determined by medical staff between cryotherapy treatment alone and combined cryotherapy and compression treatment of the upper limbs in patients treated with paclitaxel. (time frame: 7 days after completion of C3D15 or C4D1 if applicable (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.