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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    151
  • sponsor
    Centre Leon Berard
Updated on 25 January 2021
paclitaxel
breast cancer
oxaliplatin

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.

Details
Condition Colorectal Cancer, Rectal disorder, Breast Cancer, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Breast Cancer Diagnosis, breast carcinoma, colorectal neoplasm, cancer, breast, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Chilled gloves, Surgical gloves, Surgical gloves
Clinical Study IdentifierNCT03872908
SponsorCentre Leon Berard
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Rectal Disorders or Colorectal Cancer or Breast Cancer or Rectal disorder or Colon Cancer Screening or Colon cancer; rectal cancer?
Do you have any of these conditions: tumors, colorectal or cancer, breast or cancer, colorectal or Colon cancer; rectal cancer or Rectal disorder or Breast Cancer or Colon Cancer Screenin...?
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
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