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 Title: 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.

NCT ID: NCT05936034

Condition: Cancer
Ototoxicity, Drug-Induced
Quality of Life
Hearing Disorders

Conditions: Official terms:
Ototoxicity
Hearing Disorders

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Patients suffering from chemotherapy-induced ototoxicity
Description: 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.
Arm group label: Patients suffering from chemotherapy-induced ototoxicity

Intervention type: Other
Intervention name: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
Description: 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.
Arm group label: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut de Cancérologie de Lorraine

Address:
City: Vandœuvre-lès-Nancy
Zip: 54500
Country: France

Status: Recruiting

Contact:
Last name: MASTRONICOLA ROMINA, MD

Start date: January 4, 2024

Completion date: January 4, 2027

Lead sponsor:
Agency: Institut de Cancérologie de Lorraine
Agency class: Other

Source: Institut de Cancérologie de Lorraine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05936034