Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) (MELODY)

June 11, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556

The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Virtually via Zoom, all participants will meet with Music Therapists to create playlists and learn how to complete surveys measuring quality of life.

Participants will be randomly assigned, half to each arm. Arm A will interact with Music Therapists and listen to music twice a week, then independently fill out quality of life questionnaires.

Arm B will listen to music independently twice a week, then independently fill out quality of life questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Principal Investigator- Matthias Holdhoff, MD, PhD.
  • Phone Number: 410-955-8837 410-995-8837
  • Email: bcp-iis@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Oncology- Broadway
        • Contact:
          • Matthias Holdhoff, MD. PhD.
          • Phone Number: 410-955--8837
          • Email: bcp-iis@jh.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Glioblastoma
  • Cognitive capacity to respond to surveys
  • Access to computer and web access
  • Ability to attend virtual music therapy sessions
  • Audibly process music
  • Proficient in English

Exclusion Criteria:

  • Not planning to undergo standard of care radiation therapy and concurrent and adjuvant temozolomide.
  • A life expectancy of less than 6 months.
  • Concurrent use of any other standard or investigational agents (excepting tumor treating fields).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit adherence with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A- with Music Therapists
Arm A of the study will involve individuals who are assigned to receive twice weekly music therapy sessions with a Music Therapist. These live sessions will be conducted virtually via a Johns Hopkins Compliance virtual platform (e.g., Zoom) each session will last 30 minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.
Other: Music intervention

Each GBM study participant in Arm A will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be curated by a board-certified music therapist. Arm B participants will receive curated playlists of music created by a music therapist. Participants will then listen to the curated music playlists on the participant's own device twice per week.

All participants will complete a total of 16 music therapy sessions, scheduled twice per week over 8 weeks. Each session will last approximately 30 minutes.
Experimental: Arm B- without Music Therapists
Arm B of the study participants will meet with a music therapist to create a curated playlist. The participant will then listen independently to music therapy sessions twice a week for thirty minutes. Participants will complete a total of 16 music therapy sessions, and the frequency is 2 sessions per week for 8 weeks. Participants will complete surveys measuring quality of life once each week.
Other: Music intervention

Each GBM study participant in Arm A will receive two 30-minute live synchronous virtual music therapy sessions per week for a period of 8 weeks to be curated by a board-certified music therapist. Arm B participants will receive curated playlists of music created by a music therapist. Participants will then listen to the curated music playlists on the participant's own device twice per week.

All participants will complete a total of 16 music therapy sessions, scheduled twice per week over 8 weeks. Each session will last approximately 30 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate of Music Therapy intervention for GBM patients
Time Frame: 6 months
Determine success rate of the delivery of individualized virtual music therapy (MT) in participants undergoing standard of care treatment for newly diagnosed glioblastoma.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of survey completion
Time Frame: 2 years
Rate of participants completing all surveys.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Keep Punching Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grace Tobin, MD, Johns Hopkins University
  • Principal Investigator: Matthias Holdhoff, MD, PhD., Johns Hopkins -Sidney Kimmel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • J2556
  • IRB00493841 (Other Identifier: JHU IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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