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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients suffering from chemotherapy-induced ototoxicity, Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids.
- Who it may be relevant to
- Registry conditions: Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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) * 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 cli - Other Patients 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
Primary outcome measures
- Quality of life of patients [Time frame: 6 months]
Secondary outcome measures (2)
- Measuring hearing and the onset of tinnitus in patients [Time frame: 6 months]
- Patient compliance to wearing a hearing aid [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT05936034 · 2023-A02141-44