NCT03538223: MuLi_RT

Music Listening in Radiotherapy Treatment

Completed NA Last updated 20 January 2022

What this trial tests

NA trial testing Music Listening in Breast Cancer in 60 participants. Completed in 30 September 2020.

Timeline

5 March 2018

Primary endpoint
30 June 2020

30 September 2020

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	5 March 2018
Primary completion	30 June 2020
Estimated completion	30 September 2020
Sites	1 location across Italy

Drugs / interventions tested

• Music Listening
• Radiotherapy — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

Eligibility, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Music and music therapy are now widely used as non-pharmacological intervention techniques in different clinical and therapeutic settings.

The present study includes the use of musical listening related to the concept of "Music Medicine", a possibility of modifying the psycho-physiological state of the patient through the targeted use of musical pieces respondent to specific parameters and musical structures able to interact in particular conditions with the psycho-somatic imbalances to which the person is subjected.

In particular, in this study, in addition to proposing a traditional listening method, the music used in one of the research arms will be composed of an artificial intelligence called "Melomics-Health".

The objective of the study is to verify whether the perception of anxiety and stress in cancer patients undergoing Radiotherapy is influenced by music listening ("Melomics-Health" music vs listening to favorite music). Sixty breast cancer surgical patients, candidates for post-operative radiotherapy with a healing purpose. Patients who will undergo Radiation therapy for the first time in their lives will be included.

Patients will be recruited in this randomized controlled study with a sequential enrollment and, in the case of inclusion, will be assigned to one of the following 3 groups: a) "Melomics-Health" music listening group (n = 20); b) favorite music listening group (n = 20); c) no-music control group (n = 20). Music groups will undergo 15 minutes music listening immediately before the simulation and the first 5 sessions of radiotherapy.

Patients will be subjected to a psychological assessment focused on anxiety (State-Trait Anxiety Inventory) and distress (Psychological Distress Inventory) dimensions at the baseline (T0), at the end of the treatments (T1) and at the Follow-up (T2, 2 weeks after the fifth session of Radiotherapy). A specific questionnaire will also be submitted to the patients included in music groups. This questionnaire will allow the music therapist to acquire specific qualitative information regarding the different types of music listening and the responses of the subjects to them.

Descriptive statistics will be produced for all the variables detected.The effectiveness of musical listening in relation to the psychological aspects considered will be evaluated by applying analysis of variance models.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Music interventions for improving psychological and physical outcomes in people with cancer.
   Bradt J, Dileo C, Myers-Coffman K, Biondo J. · · 2021 · cited 129× · PMID 34637527 · DOI 10.1002/14651858.cd006911.pub4
2. Highlighting the Potential for Chronic Stress to Minimize Therapeutic Responses to Radiotherapy through Increased Immunosuppression and Radiation Resistance.
   Chen M, Singh AK, Repasky EA. · · 2020 · cited 14× · PMID 33419318 · DOI 10.3390/cancers12123853
3. Conventional and Algorithmic Music Listening before Radiotherapy Treatment: A Randomized Controlled Pilot Study.
   Raglio A, Oddone E, Meaglia I, Monti MC, et al · · 2021 · cited 9× · PMID 34942921 · DOI 10.3390/brainsci11121618