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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
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.
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.
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
RECRUITINGQuality 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.
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months
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