Clinical trial NCT04402593: Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study
Official title: Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With Relapsed Germ Cell Cancer (rGCC): A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Relapsed Germ Cell Cancer
Cisplatin Induced Tinnitus
Keywords: relapsed germ cell cancer
cisplatin induced tinnitus
music therapy
germ cell cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study will enroll 15 subjects to a twice a week Music Therapy intervention (modified Heidelberg Model of Neuro-Music Therapy) for 3 weeks (6 sessions total).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: This is a prospective, interventional pilot study that plans to enroll 15 patients who are receiving salvage high dose chemo and bone marrow transplant for relapsed Germ cell Cancer (rGCC). Patients will be asked to go through a series of surveys and screening procedures to determine eligibility. Once enrolled, patients will receive music therapy while they are being treated either inpatient or outpatient for their standard of care treatments.

Primary Objective To evaluate the feasibility of recruitment, retention, and compliance to a mHNMT in patients with CIT and rGCC admitted to BMT service to undergo salvage high-dose chemotherapy with tandem bone marrow rescue.

Secondary Objectives To estimate the effects of mHNMT on severity of CIT, associated distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and assess number of times homework completed.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: 30 days
measure: Retention feasibility
timeFrame: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
measure: Compliance and fidelity feasibility
timeFrame: from the start of intervention until last subject completes intervention (i.e. up to 2 years)
Secondary outcomes:
measure: Effects of intervention on severity of Cisplatin Induced Tinnitus determined by scores on the Tinnitus Functional Index
timeFrame: Baseline, day +50, day +100, and day +270
measure: Effects of intervention on associated distress determined by scores on the Tinnitus Questionnaire
timeFrame: Baseline, day +50, day +100, and day +270
measure: Effects of intervention on anxiety determined by scores on the Impact of Events Scale
timeFrame: Baseline, day +50, day +100, and day +270
measure: Effects of intervention on depression determined by scores on Hospital Anxiety and Depression Scale
timeFrame: Baseline, day +50, day +100, and day +270
measure: Effects of intervention on benefit findings determined by scores on The Benefit Finding Scale
timeFrame: Baseline, day +50, day +100, and day +270
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Adult Short Form
timeFrame: Baseline, day +50, day +100, and day +270
measure: Number of hours asleep
timeFrame: Up to 3 weeks
measure: Number of times homework completed
timeFrame: Each day of intervention until study completion, about 3 weeks
measure: Audiometric evaluation
timeFrame: Baseline and day +270 (+/- 90 days)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Debra Burns, PhD
role: PRINCIPAL_INVESTIGATOR
References: