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

Breast Cancer Clinical Trial

— ELEGANT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03872908
• Other study ID #: ELEGANT - ET18-262
• Status: Active, not recruiting
• Start date: September 29, 2019
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of Satisfaction & Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Peripheral Nervous System Diseases

Intervention

Device:
• Chilled gloves
Chilled glove for non-dominant hand (patients treated with paclitaxel)
• Surgical gloves
Surgical gloves (patients treated with oxaliplatine)

Locations

Country	Name	City	State
France	Infirmerie Protestante	Caluire-et-Cuire
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At the end of paclitaxel administration (4 to 6 months after inclusion)
Primary	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	After the end oxaliplatine administration (4 to 6 months after inclusion)
Secondary	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)	At the end of each cycle (each cycle is 7 days)
Secondary	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)	At the end of paclitaxel administration (4 to 6 months)
Secondary	Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand	Evaluation using NPSI and MRC questionnaires	Before each cycle (except the 1st one), (each cycle is 7 days)
Secondary	Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand	Evaluation using NPSI and MRC questionnaires	At the end of paclitaxel administration (4 to 6 months after inclusion)
Secondary	Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand	Evaluation using NPSI and MRC questionnaires	12 months after the end of treatment
Secondary	Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand	Evaluation using the NCI-CTCAE v5 scale	Before each cycle (except the 1st one) (each cycle is 7 days)
Secondary	Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand	Evaluation using the NCI-CTCAE v5 scale	At the end of paclitaxel administration (4 to 6 months after inclusion)
Secondary	Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand	Evalutation using NCI-CTCAE v5 scale	At the end of paclitaxel administration (4 to 6 months after inclusion)
Secondary	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)	At the end of paclitaxel administration (4 to 6 months after inclusion)
Secondary	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)	At the end of oxaliplatine administration (4 to 6 months after inclusion)
Secondary	Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand	Evaluation using a duration questionnaire	Before each cycle (except the 1st one) (each cycle is 7 days)
Secondary	Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand	Evaluation using a duration questionnaire	At the end of oxaliplatine administration (4 to 6 months after inclusion)
Secondary	Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand	Evaluation using the NPSI questionnaire	After each cycle (except the 1st one), (each cycle is 7 days)
Secondary	Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand	Evaluation using the NPSI questionnaire	At the end of oxaliplatine administration (4 to 6 months after inclusion)
Secondary	Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand	Evaluation using the NPSI questionnaire	12 months after the end of treatment.