Protection From Cisplatin Ototoxicity by Lactated Ringers
This study has been completed.
Sponsor:
University of Oklahoma
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584155
First received: December 20, 2007
Last updated: June 14, 2010
Last verified: June 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hearing Loss |
Drug: Normal Saline and 0.3% ofloxacin Drug: Lactated Ringer's with 0.03% Ofloxacin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity. |
Resource links provided by NLM:
Drug Information available for:
Ringer's lactate
Cisplatin
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Wayne Berryhill, MD, University of Oklahoma Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00584155 History of Changes |
| Other Study ID Numbers: | Lactated Ringers - Berryhill |
| Study First Received: | December 20, 2007 |
| Last Updated: | June 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by 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 Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 17, 2013