Randomized Trial Comparison of Ototoxicity Monitoring Programs
Condition: Cisplatin Ototoxicity; Hearing Loss
MeSH terms: Hearing Loss; Ototoxicity
Study type: Interventional

Summary: 
      This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing
      are termed "ototoxic". One such drug is the chemotherapy called cisplatin. Currently, if a
      patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy
      protocols and may be retested only when it is requested by their oncologist and when the
      Veteran can arrange an appointment. Researchers think that hearing testing prior to every
      treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from
      treatment. The purpose of this study is to compare the current method of monitoring hearing
      (audiology clinic protocols termed "usual care") with a new portable hearing monitoring
      program (a comprehensive program of ototoxicity monitoring termed "COMP-VA") that tests
      hearing using a portable hearing testing audiometer and a variety of efficient tools and
      techniques so that testing can occur prior to each cisplatin treatment at any quiet location
      in the hospital.
    

Detailed description: 
      Research objectives are to compare the effectiveness of ototoxicity monitoring implemented
      using Comp-VA or usual care with regard to (1) improving Veterans' hearing and quality of
      life outcomes, (2) assisting oncologists in pre-treatment counseling and therapeutic planning
      and (3) increasing use of post-treatment rehabilitative services.

      The investigators plan to recruit a total of 320 Veterans undergoing cisplatin
      chemotherapeutic treatment over 4 years and 120 control subjects.

      Program Evaluation: Hearing testing prior to treatment will be done in order to establish
      eligibility, enroll and randomize each subject into one of two study arms. At 5 weeks and at
      one year post-randomization hearing will be re-tested in order to obtain an estimate of
      longitudinal trends in hearing and quality of life assessment. Use of audiological services
      following treatment from the randomized subjects will be tracked. Finally, data will also be
      collected at each treatment interval to track use of counseling tools and oncology personnel
      treatment decisions.

      Serial measurements from subjects receiving cisplatin prior to treatment who are randomized
      to:

      Comp-VA group will get a screening hearing test prior to treatment, at each treatment
      interval and at one-month post-treatment. Auditory testing will be done on or near the Chemo
      Unit and will include otoscopy, immittance testing, and a hearing testing done by the Veteran
      using a self-testing procedure, and may be tested using distortion product otoacoustic
      emissions (DPOAEs), if they cannot take a reliable hearing test.

      Usual care group will receive a full audiometric evaluation (otoscopy, immittance testing,
      air conduction and bone conduction hearing testing, speech audiometry, and distortion product
      otoacoustic emissions, DPOAEs) scheduled in the audiology clinic sound booth according to
      Audiology Service ototoxicity monitoring protocols. Testing will be arranged according to
      availability of appointments and patient convenience.

      Additionally data will also be collected from control subjects who are similar in age and are
      tested at intervals similar to the chemotherapy subjects.
    

Intervention name(s): COMP-VA; Standard of care
Intervention type(s): Other; Other
Intervention description(s): Hearing testing at each treatment interval by the comp-va audiologist; Hearing testing done in the audiology clinic after oncology referral or patient self referral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: hearing; cisplatin; Ototoxicity; Veterans