Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted. (PROTOTOX)

January 5, 2024 updated by: Institut de Cancérologie de Lorraine

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 the 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • MASTRONICOLA ROMINA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient
  • Patient currently undergoing treatment with platinum-based chemotherapy and suffering from hypoacusia consistent with the treatment or presenting a worsening of already existing hypoacusis consistent with the start of treatment with platinum-based chemotherapy
  • Patient whose hypoacusis is confirmed by the audiometric test
  • Patient able and willing to follow all study procedures in accordance with the protocol.
  • Patient having understood, signed and dated the consent form
  • Patient affiliated to the social security system

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Persons deprived of liberty or under guardianship (including curatorship)
  • Impossibility of submitting to medical monitoring of the trial for geographical, social or psychological reasons
  • Patient with a contraindication to wearing hearing aids
  • Patient already fitted
  • Patient already included in a protocol including an experimental molecule
  • Patient who has not started treatment with platinum-based chemotherapy
  • Patient presenting only tinnitus without hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients suffering from chemotherapy-induced ototoxicity
Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.
Other: Patients suffering from chemotherapy-induced ototoxicity

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)

  • Patients will then be randomized to either:

    • Control group: standard support; 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, three and six months after fitting,

  • medical staff carries out a clinical examination
  • This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire.

Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire.
Experimental: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.
Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

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)

  • Patients will then be randomized to either:

    • Experimental group: standard treatment with hearing aids (wearing 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, three and six months after fitting,

  • medical staff carries out a clinical examination
  • This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire.

Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients
Time Frame: 6 months

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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring hearing and the onset of tinnitus in patients
Time Frame: 6 months
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
6 months
Patient compliance to wearing a hearing aid
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: ROMINA MASTRONICOLA PERNA, MD, Institut de Cancérologie de Lorraine
  • Study Chair: Naoual BOUJEDAINI, PhD, Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

July 4, 2025

Study Completion (Estimated)

January 4, 2027

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02141-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Patients suffering from chemotherapy-induced ototoxicity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe