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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suffering from chemotherapy-induced ototoxicity | Active Comparator | Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care. |
|
| Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids | Experimental | Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients suffering from chemotherapy-induced ototoxicity | Other | At baseline,
At one, three and six months after fitting,
Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality 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.](streamdown:incomplete-link) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Patient compliance to wearing a hearing aid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JEAN LOUIS MERLIN, PUPH | Contact | +33 3 83 65 60 62 | jl.merlin@nancy.unicancer.fr | |
| CECILE HUIN SCHOHN, PhD | Contact | +33 3 83 59 86 07 | c.huinschohn@nancy.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| ROMINA MASTRONICOLA, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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|
| Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids | Other | At baseline,
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,
Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire. |
|
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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000081015 | Ototoxicity |
| D006311 | Hearing Disorders |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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