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

Active, not recruiting

• Conditions: Breast Cancer; Colorectal Cancer
• Interventions: Device: Chilled gloves; Device: Surgical gloves

• Registration Number: NCT03872908
• Lead Sponsor: Centre Leon Berard

Brief Summary

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 Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-09-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 177

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Chilled gloves	Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) versus chilled gloves (non-dominant hand) at the end of paclitaxel administration.
Cohort 1	Surgical gloves	Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) versus chilled gloves (non-dominant hand) at the end of paclitaxel administration.
Cohort 2	Surgical gloves	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.

Primary Outcome Measures

Name	Time	Method
Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration.	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	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

Secondary Outcome Measures

Name	Time	Method
Cohort 2: Evaluation of the global satisfaction concerning surgical gloves wearing, comfort, pain and ease to wear	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)
Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand	At the end of paclitaxel administration (4 to 6 months after inclusion)	Evalutation using NCI-CTCAE v5 scale
Cohort 1: Evaluation of comfort and pain felt with gloves for each hand	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)
Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand	12 months after the end of treatment	Evaluation using NPSI and MRC questionnaires
Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand	At the end of paclitaxel administration (4 to 6 months after inclusion)	Evaluation using the NCI-CTCAE v5 scale
Evaluation of the ease to put on gloves for each hand	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)
Cohort 1: Evaluation of nurses's preference for the gloves wearing (surgical versus chilled gloves)	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)
Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand	At the end of oxaliplatine administration (4 to 6 months after inclusion)	Evaluation using a duration questionnaire
Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand	12 months after the end of treatment.	Evaluation using the NPSI questionnaire

Trial Locations

Locations (2)

Centre Léon Bérard; 🇫🇷 Lyon, France

Infirmerie Protestante; 🇫🇷 Caluire-et-Cuire, France