Cisplatin Induced Tinnitus Clinical Trial
Official title:
Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study
| Verified date | June 2023 |
| Source | Indiana University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Pilot study evaluating the feasibility of recruitment, retention, and compliance to a modified Heidelberg Model of Neuro-Music Therapy (mHNMT) in patients with Cisplatin-induced Tinnitus and relapsed Germ Cell Cancer (rGCC).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. = 18 years old at the time of informed consent. 2. English speaking. 3. Ability to provide written informed consent and HIPAA authorization 4. Confirmed diagnosis of CIT via a score on the TFI of 26 or greater. 5. Personal history of rGCC. 6. Previous exposure to cisplatin. 7. Admitted to BMT service to undergo HDC-tBMR for the first time. (Because this is a feasibility study, a minimum number of MT sessions will not be required). 8. Agrees not to receive music therapy outside of study. Exclusion Criteria: 1. Severe hearing impairment greater than 60 dB HL in the region of the center tinnitus frequency 2. Patient's tinnitus can not be pitch matched. 3. Clinical diagnosis of severe mental disorder or psychiatric or neurological disease such as psychosis, epilepsy, Parkinson's disease, dementia, alcohol or drug abuse. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Indiana University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recruitment feasibility | The ability to enroll at least 50% of approached subjects. | 30 days | |
| Primary | Retention feasibility | The ability to successfully retain 60% of enrolled subjects. | from the start of intervention until last subject completes intervention (i.e. up to 2 years) | |
| Primary | Compliance and fidelity feasibility | The ability to deliver over 90% of planned intervention. | from the start of intervention until last subject completes intervention (i.e. up to 2 years) | |
| Secondary | Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index | The Tinnitus Functional Index (TFI) has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. Minimum value is 1 and maximum value is 10. A higher score indicates worse tinnitus. A mean score of 25 or less than 25 indicates relatively mild tinnitus and little or need for intervention. A mean score ranging from 25-50 indicates significant problems with tinnitus and a possible need for intervention. A mean score of 50 or greater indicates tinnitus severe enough to qualify for more aggressive intervention. |
Baseline, day +50, day +100, and day +270 | |
| Secondary | Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire | For each item, individuals indicate the level of agreement by answering; not true (score 0), partly true (score 1), or true (score 2). A three point scale limits its utility as an outcome measure. Total scores range from 0-82, with higher scores indicating more distressing tinnitus. | Baseline, day +50, day +100, and day +270 | |
| Secondary | Effects of intervention on anxiety determined by scores on the Impact of Events Scale | A 22-item self-report measure that assesses subjective distress caused by traumatic events on a scale from 0-4, where 0 is not at all, and 4 is extremely. A higher score indicates increased anxiety. | Baseline, day +50, day +100, and day +270 | |
| Secondary | Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale | Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. | Baseline, day +50, day +100, and day +270 | |
| Secondary | Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale | Uses a 5-point Likert scoring method from 1 = Not at all to 5 = Extremely. | Baseline, day +50, day +100, and day +270 | |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form | Use a 5-point Likert scale and employ 7-day recall. Higher scores indicate higher levels of fatigue. Scores are standardized (M = 50, SD = 10) | Baseline, day +50, day +100, and day +270 | |
| Secondary | Number of hours asleep | Actiwatch Spectrum Pro watch. Sleep parameters will be computed using Actiware® software. The sleep parameters produced include total sleep time, sleep latency (minutes until sleep onset), sleep efficiency, frequency and duration of awakenings after sleep onset (WASO), and number of awakenings. These Sleep variables will be scored for each 24-hour period, and averages over the course of use will be computed for nighttime sleep alone and nighttime sleep plus daytime naps to be combined into epochs for assessment. | Up to 3 weeks | |
| Secondary | Number of times homework completed | This will be assessed each day of the intervention and captured using the Actiwatch Spectrum Pro and summed over the entire intervention period. | Each day of intervention until study completion, about 3 weeks | |
| Secondary | Audiometric evaluation | The Pure-tone hearing threshold audiometry (PTA) measures and classifies hearing loss into three levels: <25 dB (normal hearing); =25 dB <40 dB (mild hearing impairment); and =40 dB (moderate-to-severe hearing impairment). PTA will be measured in a soundproofing booth using an audiometer (SA 203, Entomed, Sweden), and include frequencies of 500, 1000, 2000, 3000, 4000, and 6000 Hz in both ears in accordance with the American National Standards Institute (ANSI) standard. The hearing threshold will be defined as the mean hearing threshold of the better ear on PTA tests at 500, 1000, 2000, and 4000 Hz. Hearing loss in this study will be defined as follows: <25 dB (normal hearing), =25 dB and <40 dB (mild hearing loss), and =40 dB (moderate-to-severe hearing loss). | Baseline and day +270 (+/- 90 days) |