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. (PROTOTOX)

Institut de Cancérologie de Lorraine

Status: Enrolling

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

Treatments: Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids; Other: Patients suffering from chemotherapy-induced ototoxicity

Study type: Interventional

Funder types: Other

Identifiers

NCT05936034

2023-A02141-44

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Patients suffering from chemotherapy-induced ototoxicity

Active Comparator group

Description:

Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.

Treatment:

Other: Patients suffering from chemotherapy-induced ototoxicity

Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

Experimental group

Description:

Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.

Treatment:

Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids