Satisfaction & Efficacy of Compression Using Surgical Gloves in Chemo-induced Peripheral Neuropathies (ELEGANT)

January 24, 2024 updated by: Centre Leon Berard

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caluire-et-Cuire, France, 69300
        • Infirmerie Protestante
      • Lyon, France, 69008
        • Centre Leon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with adjuvant or metastatic:

  • Breast cancer treated by Paclitaxel or,
  • Colorectal cancer treated by Oxaliplatine

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Chilled gloves
Chilled glove for non-dominant hand (patients treated with paclitaxel)
Device: Surgical gloves
Surgical gloves (patients treated with oxaliplatine)
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.
Device: Surgical gloves
Surgical gloves (patients treated with oxaliplatine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
After the end oxaliplatine administration (4 to 6 months after inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 using a numeric scale from 0 (Very uncomfortable / Painful) to 10 (Very comfortable / No pain)
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)
Evaluation using a numeric scale from 0 (Very difficult / long) to 10 (Very easy / Fast)
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)
Evaluation using NPSI and MRC questionnaires
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)
Evaluation using NPSI and MRC questionnaires
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
Evaluation using NPSI and MRC questionnaires
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)
Evaluation using the NCI-CTCAE v5 scale
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)
Evaluation using the NCI-CTCAE v5 scale
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)
Evalutation using NCI-CTCAE v5 scale
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)
Evaluation using a numeric scale from 0 (Very xxxx) to 10 (Very xxxx)
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)
Evaluation using a numeric scale from 0 (Very unsatisfied) to 10 (Very satisfied)
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)
Evaluation using a duration questionnaire
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)
Evaluation using a duration questionnaire
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)
Evaluation using the NPSI questionnaire
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)
Evaluation using the NPSI questionnaire
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.
Evaluation using the NPSI questionnaire
12 months after the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Thomas BACHELOT, MD, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2019

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

February 29, 2024

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEGANT - ET18-262

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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