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Assess Quality of Life in Hearing Aid Patients Suffering From oTOTOXicity Due to Platinum-based Chemotherapy (PROTOTOX)

Primary Purpose

Cancer, Ototoxicity, Drug-Induced, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patients suffering from chemotherapy-induced ototoxicity
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 Patients undergoing platinum-based chemotherapy with hearing loss or worsening of an existing hearing loss concordant with the start of platinum-based chemotherapy. Patient having understood, signed and dated the consent form Patient affiliated to the social security system Exclusion Criteria: Patients with contraindications to wearing hearing aids Patients already wearing hearing aids Patient already included in an other clinical study with an experimental molecule Patients who have not started platinum-based chemotherapy Patient presenting only tinnitus without hearing loss Persons deprived of liberty or under guardianship (including curators) Women who are pregnant, may become pregnant or are breast-feeding Impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients suffering from chemotherapy-induced ototoxicity

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quality of life of patients
    The quality of life of patients with hearing aids suffering from ototoxicity due to platinum-based chemotherapy will be assessed using the 36 Item Short-Form Health Survey (SF36). [score 0 to 100 : score 0 representing the lowest possible scores and score 100 representing the highest possible scores. A higher score means better health.

    Secondary Outcome Measures

    Measuring hearing and the onset of tinnitus in patients
    Hearing and the onset of tinnitus in hearing-aided patients suffering from chemotherapy-induced ototoxicity will be assessed by Hertz/Decibel measurement using an audiometer
    Patient compliance to wearing a hearing aid
    Hearing aid compliance will be assessed according to the proportion of patients completing 6-month follow-up with a hearing aid among all included patients.

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Institut de Cancérologie de Lorraine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05936034
    Brief Title
    Assess Quality of Life in Hearing Aid Patients Suffering From oTOTOXicity Due to Platinum-based Chemotherapy
    Acronym
    PROTOTOX
    Official Title
    Assess Quality of Life in Hearing Aid Patients Suffering From oTOTOXicity Due to Platinum-based Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2025 (Anticipated)
    Study Completion Date
    May 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut de Cancérologie de Lorraine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis. Improving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments have but none has led to a consensus on management. The aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients suffering from chemotherapy-induced ototoxicity
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Patients suffering from chemotherapy-induced ototoxicity
    Intervention Description
    At baseline, medical staff carries out a clinical and audiometric and/or tintometric examination patient completes the SF36 survey (36 Item Short-Form Health Survey) According to test results, the medical staff suggests that the patient be referred to a hearing aid specialist for fitting with a hearing aid. Once the patient has been fit, he continues his carcinological treatment with platinum-based chemotherapy according to the recommendations specific to his pathology. At one and three months after fitting, medical staff carries out a clinical examination patient receiving platinum-based chemotherapy completes the 36 Item Short-Form Health Survey (SF36). At six months after fitting; medical staff carries out a clinical and audiometric and/or tintometric examination patient receiving platinum-based chemotherapy completes the 36 Item Short-Form Health Survey (SF36).
    Primary Outcome Measure Information:
    Title
    Quality of life of patients
    Description
    The quality of life of patients with hearing aids suffering from ototoxicity due to platinum-based chemotherapy will be assessed using the 36 Item Short-Form Health Survey (SF36). [score 0 to 100 : score 0 representing the lowest possible scores and score 100 representing the highest possible scores. A higher score means better health.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Measuring hearing and the onset of tinnitus in patients
    Description
    Hearing and the onset of tinnitus in hearing-aided patients suffering from chemotherapy-induced ototoxicity will be assessed by Hertz/Decibel measurement using an audiometer
    Time Frame
    6 months
    Title
    Patient compliance to wearing a hearing aid
    Description
    Hearing aid compliance will be assessed according to the proportion of patients completing 6-month follow-up with a hearing aid among all included patients.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 Patients undergoing platinum-based chemotherapy with hearing loss or worsening of an existing hearing loss concordant with the start of platinum-based chemotherapy. Patient having understood, signed and dated the consent form Patient affiliated to the social security system Exclusion Criteria: Patients with contraindications to wearing hearing aids Patients already wearing hearing aids Patient already included in an other clinical study with an experimental molecule Patients who have not started platinum-based chemotherapy Patient presenting only tinnitus without hearing loss Persons deprived of liberty or under guardianship (including curators) Women who are pregnant, may become pregnant or are breast-feeding Impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ROMINA MASTRONICOLA PERNA, MD
    Phone
    +33 383 658 446
    Email
    r.mastronicola@nancy.unicancer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    JEAN LOUIS MERLIN, Pr
    Phone
    +33 383 656 062
    Email
    jl.merlin@nancy.unicancer.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ROMINA MASTRONICOLA PERNA, MD
    Organizational Affiliation
    Institut de Cancérologie de Lorraine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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