Comparing quality of life for cancer patients with hearing issues using hearing aids versus those without
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.
This study tests if giving hearing aids to cancer patients who have hearing loss from chemotherapy can improve their quality of life compared to those who don’t use hearing aids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05936034 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the quality of life in patients undergoing platinum-based chemotherapy who experience ototoxicity, specifically focusing on those fitted with hearing aids compared to those who are not. It addresses the significant side effects of chemotherapy, such as hearing loss and tinnitus, which can impact patients' overall well-being and treatment adherence. By providing hearing aids to eligible patients, the study seeks to determine if this intervention can enhance their quality of life. The study includes adult patients currently receiving treatment and suffering from confirmed hearing loss due to chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults currently undergoing platinum-based chemotherapy who have confirmed hearing loss related to their treatment.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to wearing hearing aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for cancer patients experiencing hearing loss due to chemotherapy.
How similar studies have performed: While many studies have explored the effects of chemotherapy on hearing, this specific approach of using hearing aids for quality of life improvement in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vandœuvre-lès-Nancy
- Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Romina Mastronicola, Md — Institut de Cancérologie de Lorraine
- Study coordinator: Jean Louis Merlin, Puph
- Email: jl.merlin@nancy.unicancer.fr
- Phone: +33 3 83 65 60 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.