Hearing LossPhase 1NCT00584155
Protection From Cisplatin Ototoxicity by Lactated Ringers
A Phase 1 study testing Normal Saline and 0.3% ofloxacin and Lactated Ringer's with 0.03% Ofloxacin in people with Hearing Loss, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Normal Saline and 0.3% ofloxacin and Lactated Ringer's with 0.03% Ofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
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.
Read the 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
- Hearing Loss
- Being tested
- Normal Saline and 0.3% ofloxacin, Lactated Ringer's with 0.03% Ofloxacin
- Keywords
- Cisplatin Ototoxicity, Lactated Ringer's, Ear Cancer, Hearing loss, Hearing loss due to Cisplatin Ototoxicity
- Medical subject headings
- Hearing Loss, Ear Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline and 0.3% ofloxacinDrug
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.
Lactated Ringer's with 0.03% OfloxacinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Each patient will receive a bottle containing normal saline and 0.03% ofloxacin. Receives: Drug: Normal Saline and 0.3% ofloxacin |
| 2 | Experimental | Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin. Receives: Drug: Lactated Ringer's with 0.03% Ofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJul 2006
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: PI left the university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dini Chissoe, University of Oklahoma
- Investigators
- Wayne Berryhill, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584155
- Sponsor's protocol ID
- Lactated Ringers - Berryhill
- Status last verified
- Jun 2010
- First submitted
- 20 Dec 2007
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
- ClinicalTrials.gov ID
- NCT00584155
- Acronym / sponsor ID
- Lactated Ringers - Berryhill
- Conditions
- Hearing Loss
- Keywords
- Cisplatin Ototoxicity, Lactated Ringer's, Ear Cancer, Hearing loss, Hearing loss due to Cisplatin Ototoxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the university.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Normal Saline and 0.3% ofloxacinEach patient will receive a bottle containing normal saline and 0.03% ofloxacin. |
| 2 | Experimental | Drug: Lactated Ringer's with 0.03% OfloxacinEach patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline and 0.3% ofloxacinThe 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 | 1 |
| Lactated Ringer's with 0.03% OfloxacinThe 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. | Drug | 2 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Berryhill, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Normal Saline and 0.3% ofloxacin and Lactated Ringer's with 0.03% Ofloxacin in people with Hearing Loss, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.