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.
| NCT ID | NCT05936034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut de Cancérologie de Lorraine |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-01-04 |
| Primary Completion | 2027-09-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2024-01-04 with a primary completion date of 2027-09-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
ROMINA MASTRONICOLA, MD
PRINCIPAL INVESTIGATOR
Institut de Cancérologie de Lorraine
Frequently Asked Questions
Who can join the NCT05936034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05936034 currently recruiting?
Yes, NCT05936034 is actively recruiting participants. Contact the research team at jl.merlin@nancy.unicancer.fr for enrollment information.
Where is the NCT05936034 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT05936034 clinical trial?
NCT05936034 is sponsored by Institut de Cancérologie de Lorraine. The principal investigator is ROMINA MASTRONICOLA, MD at Institut de Cancérologie de Lorraine. The trial plans to enroll 52 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.