Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study

Indiana University

Status: Withdrawn

Conditions: Cisplatin Induced Tinnitus; Relapsed Germ Cell Cancer

Treatments: Behavioral: Modified Heidelberg Model of Neuro-Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04402593

CTO-IUSCC-0673

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)

Experimental group

Description:

The mHNMT for Tinnitus program was modified based on participant feedback of the original HNMT. This study will include 6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.

Treatment:

Behavioral: Modified Heidelberg Model of Neuro-Music Therapy