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

Sponsor
Institut de Cancérologie de Lorraine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05936034
Collaborator
(none)
40
1
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients suffering from chemotherapy-induced ototoxicity
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assess Quality of Life in Hearing Aid Patients Suffering From oTOTOXicity Due to Platinum-based Chemotherapy
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
May 15, 2025
Anticipated Study Completion Date :
May 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients suffering from chemotherapy-induced ototoxicity

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) 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).

Outcome Measures

Primary Outcome Measures

  1. Quality of life of patients [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.

Secondary Outcome Measures

  1. Measuring hearing and the onset of tinnitus in patients [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

  2. Patient compliance to wearing a hearing aid [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: ROMINA MASTRONICOLA PERNA, MD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier:
NCT05936034
Other Study ID Numbers:
  • 2023-A00653-42
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023