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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Relapsed Germ Cell Cancer Cisplatin Induced Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Modified Heidelberg Model of Neuro-Music Therapy (mHNMT)

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.

Group Type EXPERIMENTAL

Modified Heidelberg Model of Neuro-Music Therapy

Intervention Type BEHAVIORAL

6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.

Interventions

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Modified Heidelberg Model of Neuro-Music Therapy

6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No