Cancer, Hearing Disorders, Ototoxicity, Drug-Induced, Quality of Life
Conditions
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 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.
Interventions
OTHERPatients 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.
OTHERPatients 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.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
CONTACTJEAN LOUIS MERLIN, PUPH
CONTACTCECILE HUIN SCHOHN, PhD
PRINCIPAL_INVESTIGATORROMINA MASTRONICOLA, MD
Institut de Cancérologie de Lorraine
Outcome results
None listed