Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05936034

Comparative Study of the Quality of Life of Patients with Chemotherapy-Induced Ototoxicity Fitted with Hearing Aids Compared to Those Not Fitted

Led by Institut de Cancérologie de Lorraine · Updated on 2025-11-28

52

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many patients receiving platinum-based chemotherapy experience hearing problems such as ototoxicity, tinnitus, and reduced hearing acuity, which can significantly affect quality of life and treatment adherence. This study aims to compare quality of life in patients suffering from chemotherapy-induced ototoxicity who are fitted with hearing aids versus those who continue with their usual care. The study is sponsored by the Institut de Cancérologie de Lorraine and addresses the lack of consensus on managing hearing side effects from platinum treatments. Participants will be randomly assigned to one of two groups: one group will continue their usual care without hearing aids, and the other group will receive standard treatment plus hearing aids. At baseline, all patients undergo clinical and audiometric examinations and complete a quality of life survey (SF36). Follow-up visits occur at one, three, and six months after fitting, including clinical and hearing assessments and repeated quality of life questionnaires. At the six-month visit, all participants complete a satisfaction questionnaire. Throughout the study, patients continue their platinum-based chemotherapy as recommended for their cancer. Researchers will measure quality of life, hearing ability, tinnitus symptoms, and patient compliance with wearing hearing aids over six months. Clinical examinations and audiometric or tinnitus tests are performed at each scheduled visit as part of standard care. The study monitors patient outcomes to evaluate the impact of hearing aids on life quality during chemotherapy treatment.

CONDITIONS

Brief Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Currently undergoing platinum-based chemotherapy
  • Experiencing hearing loss consistent with chemotherapy
  • Hearing loss confirmed by audiometric test
  • Able and willing to follow study procedures
  • Provided signed consent
  • Affiliated with social security system
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Persons deprived of liberty or under guardianship
  • Unable to undergo medical monitoring due to geographic, social, or psychological reasons
  • Contraindicated for hearing aid use
  • Already fitted with hearing aids
  • Currently enrolled in a trial with an experimental drug
  • Not yet started platinum-based chemotherapy
  • Experiencing tinnitus without hearing loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Enrollment and Baseline Assessment

Duration - 1 day

Participants undergo clinical, audiometric and/or tintometric examinations and complete the SF36 quality of life survey before being randomized to either the control group or the experimental group.

1 baseline visit (in-person)

Treatment and Monitoring

Duration - 6 months

Participants continue their platinum-based chemotherapy treatment. Those in the experimental group are fitted with hearing aids. Clinical examinations, audiometric and/or tinnitus evaluations, and SF36 quality of life questionnaires are completed at 1, 3, and 6 months after fitting.

3 visits (in-person) at 1, 3, and 6 months after fitting

Final Assessment

Duration - 1 day

At the 6-month visit, all participants complete a satisfaction questionnaire in addition to the clinical and audiometric evaluations and SF36 quality of life survey.

1 visit (in-person) at 6 months

Trial Site Locations

Total: 1 location

1

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

J

JEAN LOUIS MERLIN, PUPH

C

CECILE HUIN SCHOHN, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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