Glioblastoma (GBM)MELODYNCT07375992
Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)
A study testing Music intervention in people with Glioblastoma (GBM), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glioblastoma (Newly Diagnosed)
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oncology- Broadway
Baltimore, Maryland, 21287
Matthias Holdhoff, MD. PhD., 410-955-8837, bcp-iis@jh.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Music intervention
- Keywords
- newly diagnosed, Glioblastoma, Music Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A- with Music Therapists | Experimental | 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. Receives: Other: Music intervention |
| Arm B- without Music Therapists | Experimental | 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. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of Music Therapy intervention for GBM patients
Determine success rate of the delivery of individualized virtual music therapy (MT) in participants undergoing standard of care treatment for newly diagnosed glioblastoma.
Measured: 6 months
Secondary outcomes (1)
Rate of survey completion
Rate of participants completing all surveys.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start26 May 2026
- Primary completion26 May 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will assess the feasibility of Music Therapy in the high-risk, high-needs population of individuals newly diagnosed with GBM and undergoing standard of care adjuvant chemotherapy.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Keep Punching Foundation
- Responsible party
- Sponsor
- Investigators
- Matthias Holdhoff, MD, PhD., Principal investigator, Johns Hopkins -Sidney Kimmel Cancer CenterGrace Tobin, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375992
- Sponsor's protocol ID
- J2556
- Other IDs
- IRB00493841
- Acronym
- MELODY
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556
- ClinicalTrials.gov ID
- NCT07375992
- Acronym / sponsor ID
- MELODY / J2556
- Conditions
- Glioblastoma (GBM)
- Keywords
- newly diagnosed, Glioblastoma, Music Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Keep Punching Foundation
- Study start
- 26 May 2026 (actual)
- Primary completion
- 26 May 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will assess the feasibility of Music Therapy in the high-risk, high-needs population of individuals newly diagnosed with GBM and undergoing standard of care adjuvant chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Arm A- with Music Therapists | Experimental | Other: Music interventionArm 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. |
| Arm B- without Music Therapists | Experimental | Other: Music interventionArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Glioblastoma (Newly Diagnosed)
- Cognitive capacity to respond to surveys
- Access to computer and web access
- Ability to attend virtual music therapy sessions
- Audibly process music
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionEach 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. | Other | Arm A- with Music Therapists, Arm B- without Music Therapists |
Primary outcome
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.
1 secondary outcome
Rate of survey completion
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Holdhoff, MD, PhD. principal investigator
Johns Hopkins -Sidney Kimmel Cancer Center
Grace Tobin, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Glioblastoma (GBM), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator- Matthias Holdhoff, MD, PhD. (410-995-8837, bcp-iis@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of Music Therapy intervention for GBM patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.