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.

Cancer Clinical Trial

— PROTOTOX  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936034
• Other study ID #: 2023-A02141-44
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: January 4, 2027

Study information

• Verified date: January 2024
• Source: Institut de Cancérologie de Lorraine
• Contact: ROMINA MASTRONICOLA PERNA, MD
• Phone: +33 383 658 446
• Email: r.mastronicola[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 4, 2027
• Est. primary completion date: July 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hearing Disorders
• Ototoxicity
• Quality of Life

Intervention

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 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
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

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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
Secondary	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.	6 months