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Protection From Cisplatin Ototoxicity by Lactated Ringers

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ClinicalTrials.gov Identifier: NCT00584155
Recruitment Status : Withdrawn (PI left the university.)
First Posted : January 2, 2008
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dini Chissoe, University of Oklahoma

Brief Summary:
The purpose of this study is to determine if Lactated Ringer's solution is effective in patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to cisplatin-induced hearing loss.

Condition or disease Intervention/treatment Phase
Hearing Loss Drug: Normal Saline and 0.3% ofloxacin Drug: Lactated Ringer's with 0.03% Ofloxacin Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
Study Start Date : July 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010


Arm Intervention/treatment
Placebo Comparator: 1
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
Drug: Normal Saline and 0.3% ofloxacin
The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear and are only to be used in the designated ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.

Experimental: 2
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
Drug: Lactated Ringer's with 0.03% Ofloxacin
The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.




Primary Outcome Measures :
  1. 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. [ Time Frame: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584155


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Wayne Berryhill, MD University of Oklahoma

Responsible Party: Dini Chissoe, Study Coordinator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00584155     History of Changes
Other Study ID Numbers: Lactated Ringers - Berryhill
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: June 2010

Keywords provided by Dini Chissoe, University of Oklahoma:
Cisplatin Ototoxicity
Lactated Ringer's
Ear Cancer
Hearing loss
Hearing loss due to Cisplatin Ototoxicity

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cisplatin
Ofloxacin
Levofloxacin
Antineoplastic Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors