Trials / Withdrawn
WithdrawnNCT00584155
Protection From Cisplatin Ototoxicity by Lactated Ringers
Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2008-01-02
- Last updated
- 2015-05-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00584155. Inclusion in this directory is not an endorsement.