Can digital music therapy ease chemo side effects? new trial aims to find out
NCT ID NCT07541664
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a digital mind-body therapy that uses music and biofeedback to help women with advanced breast cancer who are undergoing chemotherapy before surgery. The goal is to see if it can reduce sleep problems, anxiety, and depression. Sixty-six participants will be randomly assigned to receive the therapy or standard care, and their symptoms will be tracked over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Digital Mind-Body Therapy (DMBT) using digital music and biofeedback
- What this could lead to
- If it works, this could offer a non-drug way to help breast cancer patients sleep better and feel less anxious or depressed during chemotherapy.
- What could go wrong
- This is a small, early-stage trial with only 66 participants, so results may not apply to everyone. The therapy is behavioral, so benefits may be modest and depend on patient engagement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants voluntarily agree to take part in this study and provide written informed consent. 2. Female, aged ≥18 years. 3. Histologically confirmed invasive breast cancer. 4. Planned to receive neoadjuvant therapy. 5. Completion of psychosomatic assessment prior to initiation of neoadjuvant therapy, with at least two of the following domains reaching mild or higher severity: anxiety, depression, insomnia, or psychological distress (severity classified according to established clinical cut-off values of the respective assessment scales). 6. Good compliance and willingness to adhere to follow-up. 7. Normal hearing, without severe hearing impairment. 8. Possession of a smartphone and ability to independently operate mobile applications. Exclusion Criteria: 1. Presence of distant metastasis. 2. History of other malignancies, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers with disease-free survival \>5 years. 3. Immunodeficiency or human immunodeficiency virus (HIV) infection. 4. Severe dysfunction of the heart, lungs, liver, or kidneys. 5. Uncontrolled infection or active infection. 6. Pregnant or lactating women. 7. Markedly abnormal psychological or cognitive status that precludes completion of psychosomatic assessment. 8. Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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