Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.
Institut de Cancérologie de Lorraine
52 participants
Jan 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05936034