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Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.


Phase 1
18 Years
N/A
Not Enrolling
Both
Hearing Loss

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Trial Information

Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.


About one-third of people who have been given Cisplatin, as part of their chemotherapy
treatment, develop hearing loss. The purpose of this study is to determine if some degree
of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To
study this, patients will use drops in their ears; Lactated Ringer's will be placed in one
ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop
antibiotic will be placed in each ear at the same time. Each participant will receive a
hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after
the final treatment.


Inclusion Criteria:



- Patients with cancer to be treated with cisplatin.

- Patients expected to receive a minimum of 3 rounds of chemotherapy.

- Patients receiving a minimum dose of cisplatin of 70 mg/m2

Exclusion Criteria:

- Patients who have had middle ear surgery.

- Patients who have active external or middle ear disease

- Patients who have preceding pure tone average of >40 dB HL

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Pre-treatment audiogram will be compared with the post treatment audiogram. The differences between the two will be calculated and compared to the differences in the opposite ear.

Outcome Time Frame:

Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy

Safety Issue:

Yes

Principal Investigator

Wayne Berryhill, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

Lactated Ringers - Berryhill

NCT ID:

NCT00584155

Start Date:

July 2006

Completion Date:

June 2010

Related Keywords:

  • Hearing Loss
  • Cisplatin Ototoxicity
  • Lactated Ringer's
  • Ear Cancer
  • Hearing loss
  • Hearing loss due to Cisplatin Ototoxicity
  • Hearing Loss
  • Deafness

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104