PROTOTOX: Assess Quality of Life in Hearing Aid Patients Suffering From oTOTOXicity Due to Platinum-based Chemotherapy
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 |
|---|---|---|
|
N/A |
Study Design
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
- 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
- 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
- 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
Inclusion Criteria:
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Age ≥ 18
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Patients undergoing platinum-based chemotherapy with hearing loss or worsening of an existing hearing loss concordant with the start of platinum-based chemotherapy.
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Patient having understood, signed and dated the consent form
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Patient affiliated to the social security system
Exclusion Criteria:
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Patients with contraindications to wearing hearing aids
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Patients already wearing hearing aids
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Patient already included in an other clinical study with an experimental molecule
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Patients who have not started platinum-based chemotherapy
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Patient presenting only tinnitus without hearing loss
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Persons deprived of liberty or under guardianship (including curators)
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Women who are pregnant, may become pregnant or are breast-feeding
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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.- 2023-A00653-42