Breast CancerELEGANTNCT03872908
Satisfaction & Efficacy of Compression Using Surgical Gloves in Chemo-induced Peripheral Neuropathies
An observational study of Breast Cancer and Colorectal Cancer, run by Centre Leon Berard at 2 sites in France.
Trial summary
Evaluation of Satisfaction \& Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer
- What is being tested?
- Chilled gloves and Surgical gloves
- Type of treatment
- Medical device
- How many people
- 177 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Sep 2019to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adjuvant or metastatic: * Breast cancer treated by Paclitaxel or, * Colorectal cancer treated by Oxaliplatine
Who may be able to join
- Age >= 18 years old
- Breast cancer requiring a treatment by paclitaxel or colorectal cancer requiring a treatment by oxaliplatine
- At least 8 chemotherapy cycles planned
- Able to understand, read and write French language
- Covered by a social insurance
- Dated and signed informed consent
Who cannot join
- Pre-existing neuropathy or history of neuropathy
- Psychological, family, sociological or georgraphical condition that may potentially compromise the adherence to study protocol and follow up
- Cohort 1: Patients presenting a Raynaud's syndrome (contra-indication to cold temperatures)
- Participation to clinical trial which may interfere with the evaluation of the main endpoints.
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Infirmerie Protestante
Caluire-et-Cuire, 69300
Centre Léon Bérard
Lyon, 69008
About this study
Official title: Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies
Evaluation of Satisfaction \& Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy
Read the detailed description
Peripheral neuropathy (PN) is an adverse event of numerous chemotherapy agents commonly used, including taxanes (paclitaxel, docetaxel) and platinum-based treatments (oxaliplatine, cisplatine, carboplatine).
Taxanes are widely used in breast cancer. Docetaxel and paclitaxel became indispensable during the last decade in metastatic and early stage breast cancer treatment. For platinum-based chemotherapies, oxaliplatine is one of the main molecules used in digestive oncology, particularly in colorectal cancer.
The limiting toxicities of taxanes and platinum-based treatments which can lead to the therapeutic scheme modification (therefore to a potential diminution of efficacy and eventually to treatment stop) are mainly hematologic (neutropenia) and neurological, the most frequent neuro-toxicity event being a PN associated or not to neuropathic pains. The PN induced by chemotherapy can occur prematurely during the treatment course, persist between the treatments' cycles and last a long time after the end of cycles, with an impact on patients' quality of life. Symptoms are mainly sensitive, including pain, paresthesia and hands / foot numbness. These symptoms, as the hematologic toxicity, represent a major limiting factor for the treatment.
According to the ASCO recommendations, there is no effective prophylactic method against the chemo-induced PN. In a retrospective study, the chilled gloves used for preventing the nail lesions during chemotherapy may reduce the incidence of docetaxel-induced PN. Recently, the surgical gloves efficacy against paclitaxel-induced PN has been evaluated prospectively in women presenting a metastatic or early stage breast cancer, with a percentage of grade >=2 NP significantly lower for the hand protected by surgical gloves than the control hand without glove (compression-induced vasoconstriction responsible for a blood flow reduction in the hands and therefore for the local exposure to chemotherapy agents) and a good tolerance.
Chilled gloves, which use the same principle of vasoconstriction through cold, are also used in the current practice for preventing the PN occurrence. However, contrary to surgical gloves, they can be not well tolerated since the very first cycles (intolerance to cold sensation).
The objective of this study is to evaluate the medium and long term efficacy of compression induced by surgical gloves against the PN development in two frequent indications in oncology, patients treated with paclitaxel (breast cancer) or oxaliplatine (colorectal cancer) and patients' satisfaction.
- Conditions
- Breast Cancer, Colorectal Cancer
- Being tested
- Chilled gloves, Surgical gloves
- Keywords
- Breast cancer, Colorectal cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chilled glovesDevice
Chilled glove for non-dominant hand (patients treated with paclitaxel)
Surgical glovesDevice
Surgical gloves (patients treated with oxaliplatine)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) versus chilled gloves (non-dominant hand) at the end of paclitaxel administration. Receives: Device: Chilled gloves; Device: Surgical gloves | |
| Cohort 2 | Evaluation of the efficacy of the compression induced by surgical gloves against peripheral neuropathies in patients treated by oxaliplatine after a 595 mg/m2 cumulated dose. Receives: Device: Surgical gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration.
Global patient's satisfaction evaluated for each hand using a numeric scale from 0 (very unsatisfied) to 10 (very satisfied)
Measured: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 2: Efficacy of compression induced by surgical gloves vs peripheral neuropathies development in patients treated by oxaliplatine after a cumulative dose of 595 mg/m2
Percentage of NP grade >= 2 after a cumulative dose of 595 mg/m2 using NCI-CTCAE v5
Measured: After the end oxaliplatine administration (4 to 6 months after inclusion)
Secondary outcomes (15)
Cohort 1: Evaluation of comfort and pain felt with gloves for each hand
Evaluation using a numeric scale from 0 (Very uncomfortable / Painful) to 10 (Very comfortable / No pain)
Measured: At the end of each cycle (each cycle is 7 days)
Evaluation of the ease to put on gloves for each hand
Evaluation using a numeric scale from 0 (Very difficult / long) to 10 (Very easy / Fast)
Measured: At the end of paclitaxel administration (4 to 6 months)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Evaluation using NPSI and MRC questionnaires
Measured: Before each cycle (except the 1st one), (each cycle is 7 days)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Evaluation using NPSI and MRC questionnaires
Measured: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Evaluation using NPSI and MRC questionnaires
Measured: 12 months after the end of treatment
Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand
Evaluation using the NCI-CTCAE v5 scale
Measured: Before each cycle (except the 1st one) (each cycle is 7 days)
Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand
Evaluation using the NCI-CTCAE v5 scale
Measured: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand
Evalutation using NCI-CTCAE v5 scale
Measured: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of nurses's preference for the gloves wearing (surgical versus chilled gloves)
Evaluation using a numeric scale from 0 (Very xxxx) to 10 (Very xxxx)
Measured: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the global satisfaction concerning surgical gloves wearing, comfort, pain and ease to wear
Evaluation using a numeric scale from 0 (Very unsatisfied) to 10 (Very satisfied)
Measured: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand
Evaluation using a duration questionnaire
Measured: Before each cycle (except the 1st one) (each cycle is 7 days)
Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand
Evaluation using a duration questionnaire
Measured: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Evaluation using the NPSI questionnaire
Measured: After each cycle (except the 1st one), (each cycle is 7 days)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Evaluation using the NPSI questionnaire
Measured: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Evaluation using the NPSI questionnaire
Measured: 12 months after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start29 Sep 2019
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas BACHELOT, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872908
- Sponsor's protocol ID
- ELEGANT - ET18-262
- Acronym
- ELEGANT
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2019
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanvic B, Joureau-Chabert A, Ouldbey Y, Toussaint P, Chanel E, Blanc E, Heudel P, Montagnier V, Perol D, Bachelot T. Compression therapy with surgical gloves compared to cold therapy with frozen gloves in preventing paclitaxel-induced peripheral neuropathy: Results from the prospective ELEGANT trial in patients with breast cancer. Eur J Cancer. 2025 Oct 16;229:115791. doi: 10.1016/j.ejca.2025.115791. Epub 2025 Sep 12.
PubMed 40961808
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies
- ClinicalTrials.gov ID
- NCT03872908
- Acronym / sponsor ID
- ELEGANT / ELEGANT - ET18-262
- Conditions
- Breast Cancer, Colorectal Cancer
- Keywords
- Breast cancer, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 13 Mar 2019 (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.
Evaluation of Satisfaction \& Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy
Detailed description
Peripheral neuropathy (PN) is an adverse event of numerous chemotherapy agents commonly used, including taxanes (paclitaxel, docetaxel) and platinum-based treatments (oxaliplatine, cisplatine, carboplatine).
Taxanes are widely used in breast cancer. Docetaxel and paclitaxel became indispensable during the last decade in metastatic and early stage breast cancer treatment. For platinum-based chemotherapies, oxaliplatine is one of the main molecules used in digestive oncology, particularly in colorectal cancer.
The limiting toxicities of taxanes and platinum-based treatments which can lead to the therapeutic scheme modification (therefore to a potential diminution of efficacy and eventually to treatment stop) are mainly hematologic (neutropenia) and neurological, the most frequent neuro-toxicity event being a PN associated or not to neuropathic pains. The PN induced by chemotherapy can occur prematurely during the treatment course, persist between the treatments' cycles and last a long time after the end of cycles, with an impact on patients' quality of life. Symptoms are mainly sensitive, including pain, paresthesia and hands / foot numbness. These symptoms, as the hematologic toxicity, represent a major limiting factor for the treatment.
According to the ASCO recommendations, there is no effective prophylactic method against the chemo-induced PN. In a retrospective study, the chilled gloves used for preventing the nail lesions during chemotherapy may reduce the incidence of docetaxel-induced PN. Recently, the surgical gloves efficacy against paclitaxel-induced PN has been evaluated prospectively in women presenting a metastatic or early stage breast cancer, with a percentage of grade >=2 NP significantly lower for the hand protected by surgical gloves than the control hand without glove (compression-induced vasoconstriction responsible for a blood flow reduction in the hands and therefore for the local exposure to chemotherapy agents) and a good tolerance.
Chilled gloves, which use the same principle of vasoconstriction through cold, are also used in the current practice for preventing the PN occurrence. However, contrary to surgical gloves, they can be not well tolerated since the very first cycles (intolerance to cold sensation).
The objective of this study is to evaluate the medium and long term efficacy of compression induced by surgical gloves against the PN development in two frequent indications in oncology, patients treated with paclitaxel (breast cancer) or oxaliplatine (colorectal cancer) and patients' satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Chilled gloves, Device: Surgical glovesEvaluation of patient's satisfaction when wearing surgical gloves (dominant hand) versus chilled gloves (non-dominant hand) at the end of paclitaxel administration. |
| Cohort 2 | – | Device: Surgical glovesEvaluation of the efficacy of the compression induced by surgical gloves against peripheral neuropathies in patients treated by oxaliplatine after a 595 mg/m2 cumulated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adjuvant or metastatic: * Breast cancer treated by Paclitaxel or, * Colorectal cancer treated by Oxaliplatine
Key inclusion criteria (6 listed)
- Age >= 18 years old
- Breast cancer requiring a treatment by paclitaxel or colorectal cancer requiring a treatment by oxaliplatine
- At least 8 chemotherapy cycles planned
- Able to understand, read and write French language
- Covered by a social insurance
Key exclusion criteria (5 listed)
- Pre-existing neuropathy or history of neuropathy
- Psychological, family, sociological or georgraphical condition that may potentially compromise the adherence to study protocol and follow up
- Cohort 1: Patients presenting a Raynaud's syndrome (contra-indication to cold temperatures)
- Participation to clinical trial which may interfere with the evaluation of the main endpoints.
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Chilled glovesChilled glove for non-dominant hand (patients treated with paclitaxel) | Device | Cohort 1 |
| Surgical glovesSurgical gloves (patients treated with oxaliplatine) | Device | Cohort 1, Cohort 2 |
Primary outcome
Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration.
Time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)
Global patient's satisfaction evaluated for each hand using a numeric scale from 0 (very unsatisfied) to 10 (very satisfied)
Cohort 2: Efficacy of compression induced by surgical gloves vs peripheral neuropathies development in patients treated by oxaliplatine after a cumulative dose of 595 mg/m2
Time frame: After the end oxaliplatine administration (4 to 6 months after inclusion)
Percentage of NP grade >= 2 after a cumulative dose of 595 mg/m2 using NCI-CTCAE v5
15 secondary outcomes
Cohort 1: Evaluation of comfort and pain felt with gloves for each hand
Time frame: At the end of each cycle (each cycle is 7 days)
Evaluation of the ease to put on gloves for each hand
Time frame: At the end of paclitaxel administration (4 to 6 months)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Time frame: Before each cycle (except the 1st one), (each cycle is 7 days)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand
Time frame: 12 months after the end of treatment
Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand
Time frame: Before each cycle (except the 1st one) (each cycle is 7 days)
Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand
Time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand
Time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 1: Evaluation of nurses's preference for the gloves wearing (surgical versus chilled gloves)
Time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the global satisfaction concerning surgical gloves wearing, comfort, pain and ease to wear
Time frame: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand
Time frame: Before each cycle (except the 1st one) (each cycle is 7 days)
Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand
Time frame: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Time frame: After each cycle (except the 1st one), (each cycle is 7 days)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Time frame: At the end of oxaliplatine administration (4 to 6 months after inclusion)
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand
Time frame: 12 months after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 40961808Hanvic B, Joureau-Chabert A, Ouldbey Y, Toussaint P, Chanel E, Blanc E, Heudel P, Montagnier V, Perol D, Bachelot T. Compression therapy with surgical gloves compared to cold therapy with frozen gloves in preventing paclitaxel-induced peripheral neuropathy: Results from the prospective ELEGANT trial in patients with breast cancer. Eur J Cancer. 2025 Oct 16;229:115791. doi: 10.1016/j.ejca.2025.115791. Epub 2025 Sep 12.
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
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. This study is not recruiting at the moment.
Thomas BACHELOT, MD principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Centre Leon Berard at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration. (time frame: At the end of paclitaxel administration (4 to 6 months after inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872908, which also lists 1 linked publication.
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 25 Jan 2024.