Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
Overview
- Phase
- Phase 1
- Intervention
- Normal Saline and 0.3% ofloxacin
- Conditions
- Hearing Loss
- Sponsor
- University of Oklahoma
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Dini Chissoe
Study Coordinator
University of Oklahoma
Eligibility 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
Arms & Interventions
1
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
Intervention: Normal Saline and 0.3% ofloxacin
2
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
Intervention: Lactated Ringer's with 0.03% Ofloxacin
Outcomes
Primary Outcomes
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