Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
Location status: Recruiting
Location contact
CECILE HUIN SCHOHN, PhD
CONTACT
JEAN LOUIS MERLIN, MD
CONTACT
ROMINA MASTRONICOLA, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: 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.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Cancer
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Ear Diseases
Hearing Disorders
Neoplasms
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Ototoxicity
Ototoxicity, Drug-Induced
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Quality of Life
Radiation Injuries
Sensation Disorders
Signs and Symptoms
Wounds and Injuries
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Patients suffering from chemotherapy-induced ototoxicity
OtherAt 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
OtherAt 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.
Primary outcomes
-
Quality of life of patients
Time frame: 6 months
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.
Secondary outcomes
-
Measuring hearing and the onset of tinnitus in patients
Time frame: 6 months
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
-
Patient compliance to wearing a hearing aid
Time frame: 6 months
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.
Study contacts
Contact information is provided by the study sponsor or research team.
CECILE HUIN SCHOHN, PhD
CONTACT
JEAN LOUIS MERLIN, PUPH
CONTACT
Sponsors and collaborators
Lead sponsor
Institut de Cancérologie de Lorraine
Other
Registry information
Acronym: PROTOTOX
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jul 7, 2023
- Registry last updated
- Nov 28, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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