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

NCT03872908 | Unknown

• 1 other identifier: ELEGANT - ET18-262
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Breast cancer; Colorectal cancer

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (15)

• 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 of the ease to put on gloves for each hand

  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

  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

  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

  12 months after the end of treatment

Study Arms (2)

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; 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.

Device: Surgical gloves

Interventions

Chilled gloves DEVICE

Chilled glove for non-dominant hand (patients treated with paclitaxel)

Cohort 1

Surgical gloves DEVICE

Surgical gloves (patients treated with oxaliplatine)

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adjuvant or metastatic: * Breast cancer treated by Paclitaxel or, * Colorectal cancer treated by Oxaliplatine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (1)

• 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.

  PMID: 40961808 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Interventions

Gloves, Surgical

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Gloves, Protective; Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Surgical Attire; Surgical Equipment; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Thomas BACHELOT, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 13, 2019
• Study Start: September 29, 2019
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

FR (2)