Clinical trial NCT05936034: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Ototoxicity, Drug-Induced
Quality of Life
Hearing Disorders
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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

Primary outcomes:
measure: Quality of life of patients
timeFrame: 6 months
Secondary outcomes:
measure: Measuring hearing and the onset of tinnitus in patients
timeFrame: 6 months
measure: Patient compliance to wearing a hearing aid
timeFrame: 6 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: ROMINA MASTRONICOLA PERNA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cancérologie de Lorraine
name: Naoual BOUJEDAINI, PhD
role: STUDY_CHAIR
References: