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Acute Myeloid LeukemiaNCT06286332

Individualized Music Listening in Acute Leukemia Patients With Fatigue

A study testing Music Therapy in people with Acute Myeloid Leukemia and Fatigue, run by Chang Gung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia, Fatigue
What is being tested?
Music Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Apr 2024to 30 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosed with acute myeloid leukemia by a clinical specialist.
  • Patients undergoing chemotherapy for the first time.
  • Aged 18 years or older, capable of communicating in Mandarin or Taiwanese.
  • Normal hearing ability.
  • No history of psychiatric disorders and clear consciousness.
  • Participants with no prior involvement in any intervention studies related to fatigue management.
  • Demonstrates understanding of the research objectives, willingly participates in the study, and completes the informed consent form.
  • Willing to cooperate with study procedures throughout the research period.

Who cannot join

  • Severe hearing impairment.
  • Individuals with unstable vital signs or altered consciousness.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan, 333

Other trials in Taiwan

About this study

Official title: The Effectiveness of Individualized Music Listening in Acute Leukemia Patients With Fatigue on Fatigue and Laboratory Values in Acute Leukemia Patients Undergoing Chemotherapy

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.

Read the detailed description

The researchers will explain the study objectives and methods, obtain informed consent, and have participants sign the consent form before commencing the study. Participants are randomly assigned to Group A and Group B. Participants in Group A undergo 30 minutes of self-selected music playback every day in addition to receiving standard therapy, while participants in Group B only receive standard therapy. The entire study duration spans 21 days.

Being tested
Music Therapy
Keywords
AML, Music, Fatigue
Medical subject headings
Leukemia, Myeloid, Acute, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music TherapyOther

    30 minutes of self-selected music playback every day.

Study groups in NCT06286332
Study groupRoleWhat they receive
Individualized Music-Listening GroupExperimentalParticipants received self-selected music app playback for 30 minutes every day and standard therapy. The entire study duration spans 21 days.
Receives: Other: Music Therapy
Standard Care GroupNo interventionParticipants only received standard care during the entire study duration span of 21 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fatigue Score on the Tang Fatigue Rating Scale (TFRS)

    The primary endpoint was the change in TFRS total score from baseline (T0) to Day 21 (T21). The TFRS is a validated, self-reported instrument assessing average fatigue intensity (37 items, scale 1-10, total score 37-370; higher scores indicate greater fatigue).

    Measured: Baseline (T0) to Day 21 (T21)

  2. Change in 11-point Numeric Rating Scale (NRS-11) Score at Day 21 Relative to Day 1.

    Daily fatigue trajectory and change at Day 21 relative to Day 1 were assessed using the NRS-11. The NRS-11 is a validated, self-reported instrument assessing average fatigue intensity. NRS-11 scores range from 0 (no fatigue) to 10 (worst possible fatigue). A negative change score indicates a reduction in fatigue severity.

    Measured: Day 1 to Day 21.

Secondary outcomes (3)

  1. Albumin

    Albumin levels were assessed through routine clinical blood tests.

    Measured: Day 21

  2. Hemoglobin

    Hemoglobin levels were assessed through routine clinical blood tests.

    Measured: Day 21

  3. Absolute Neutrophil Count（ANC)

    Absolute neutrophil count (ANC) was assessed through routine clinical blood tests.

    Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Jan 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286332
Sponsor's protocol ID
Interventional
Status last verified
Oct 2026
First submitted
22 Feb 2024
Last updated
29 Oct 2026
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • AlFayyad I, Al-Tannir M, Yaqub M, Heena H, AlMukaibil N, Ghazwani M, Abu-Shaheen A. Clinically Significant Fatigue in Adult Leukemia Patients: Prevalence, Predictors, and Impact on Quality of Life. Cureus. 2020 Dec 23;12(12):e12245. doi: 10.7759/cureus.12245.

    PubMed 33500864

  • Schumacher A, Wewers D, Heinecke A, Sauerland C, Koch OM, van de Loo J, Buchner T, Berdel WE. Fatigue as an important aspect of quality of life in patients with acute myeloid leukemia. Leuk Res. 2002 Apr;26(4):355-62. doi: 10.1016/s0145-2126(01)00145-x.

    PubMed 11839378

  • Rutkowski S, Czech O, Wrzeciono A, Kiper P, Szczepanska-Gieracha J, Malicka I. Virtual reality as a chemotherapy support in treatment of anxiety and fatigue in patients with cancer: A systematic review and meta-analysis and future research directions. Complement Ther Med. 2021 Sep;61:102767. doi: 10.1016/j.ctim.2021.102767. Epub 2021 Aug 14.

    PubMed 34403772

  • Sezgin MG, Bektas H. The effect of music therapy interventions on fatigue in patients with hematological cancers: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2022 Nov;30(11):8733-8744. doi: 10.1007/s00520-022-07198-w. Epub 2022 Jun 11.

    PubMed 35689676

  • Burns DS, Azzouz F, Sledge R, Rutledge C, Hincher K, Monahan PO, Cripe LD. Music imagery for adults with acute leukemia in protective environments: a feasibility study. Support Care Cancer. 2008 May;16(5):507-13. doi: 10.1007/s00520-007-0330-z. Epub 2007 Sep 22.

    PubMed 17891547

  • Cassileth BR, Vickers AJ, Magill LA. Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cancer. 2003 Dec 15;98(12):2723-9. doi: 10.1002/cncr.11842.

    PubMed 14669295

  • Reimnitz L, Silverman MJ. A randomized pilot study of music therapy in the form of patient-preferred live music on fatigue, energy and pain in hospitalized adult oncology patients on a blood and marrow transplant unit. Arts Health. 2020 Jun;12(2):154-168. doi: 10.1080/17533015.2018.1534251. Epub 2018 Oct 18.

    PubMed 31038430

  • Miladinia M, Voss JG, Molavynejad S, Malehi AS, Zarea K, Nouri EM, Ahmadzadeh A. Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Nov;17(11):e1614-e1621. doi: 10.1200/OP.21.00156. Epub 2021 Jun 2.

    PubMed 34077243

  • Bates D, Bolwell B, Majhail NS, Rybicki L, Yurch M, Abounader D, Kohuth J, Jarancik S, Koniarczyk H, McLellan L, Dabney J, Lawrence C, Gallagher L, Kalaycio M, Sobecks R, Dean R, Hill B, Pohlman B, Hamilton BK, Gerds AT, Jagadeesh D, Liu HD. Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study. Biol Blood Marrow Transplant. 2017 Sep;23(9):1567-1572. doi: 10.1016/j.bbmt.2017.05.015. Epub 2017 May 19.

    PubMed 28533058

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy in people with Acute Myeloid Leukemia and Fatigue, run by Chang Gung University at 1 site in Taiwan.

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 8 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 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 Taiwan. 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?

Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fatigue Score on the Tang Fatigue Rating Scale (TFRS) (time frame: Baseline (T0) to Day 21 (T21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06286332, which also lists 10 linked publications.

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 29 Oct 2026.

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