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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut de Cancérologie de Lorraine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patients suffering from chemotherapy-induced ototoxicity

    Other intervention

    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.

  • Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

    Other intervention

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Patients suffering from chemotherapy-induced ototoxicityActive comparator 1 intervention
Group B: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aidsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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