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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jan 2024
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
January 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 4, 2028
November 28, 2025
November 1, 2025
3.7 years
June 21, 2023
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Measuring hearing and the onset of tinnitus in patients
6 months
Patient compliance to wearing a hearing aid
6 months
Study Arms (2)
Patients suffering from chemotherapy-induced ototoxicity
ACTIVE COMPARATORArm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.
Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
EXPERIMENTALArm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROMINA MASTRONICOLA, MD
Institut de Cancérologie de Lorraine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2023
First Posted
July 7, 2023
Study Start
January 4, 2024
Primary Completion (Estimated)
September 4, 2027
Study Completion (Estimated)
July 4, 2028
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share