Clinical trial · Interventional
Protection From Cisplatin Ototoxicity by Lactated Ringers
Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
NCT00584155CI-TRIAL-00018049withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left the university.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactated Ringer's with 0.03% Ofloxacin | Drug | — | UNRESOLVED |
| Normal Saline and 0.3% ofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
- interventionNames
- Drug: Normal Saline and 0.3% ofloxacin
- type
- EXPERIMENTAL
- label
- 2
- description
- Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
- interventionNames
- Drug: Lactated Ringer's with 0.03% Ofloxacin
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.