Musas project: music for alleviating symptoms impact of Music in fatigue and emotion of women with breast Cancer: a three-arm randomized control trial

INTERVENTION: This is a three‐arm, non‐blinded, randomized controlled clinical trial. The participant will be approached and explained about the Musas project, objectives and possibilities of randomization ("raffle") to one of the 3 groups.The (1) experimental group "Clotilde", Music Therapy, 25 participants will listen to a personalized selection of songs (45 minutes long) during one cycle of chemotherapy (according to interview with Music Therapist and data collection). The (2) experimental group "Cecilia", Music and Medicine, 25 participants will listen to a standardized selection of songs (45 minutes long), according to previous studies, during one cycle of chemotherapy. Both these groups will be recommended to listen to one song per day from the same selection every day until T3 (about 21 days after the first cycle). The (3) control group "Irene", 25 participants will receive the standard treatment at chemotherapy and listen to a selection of standardized songs starting with the following infusion cycle (but outcomes will be measured in a previous cycle) ‐‐ this strategy is only to minimize the risk of bias from participants. The sum of patient number in the three groups gives a total sample size of 75. CONDITION: C04.588.180 Fatigue; Psychological Distress; Quality of Life; Drug‐Related Side Effects and Adverse Reactions PRIMARY OUTCOME: A decrease in cancer‐related fatigue, as assessed by the FACT‐F scale, is expected to be found within a difference of 10%, in the experimental groups compared to the control group ‐‐ with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention. We expect to find a decrease in cancer‐related fatigue, as assessed by IL‐10 (interleukin 10) test, with a mean difference of at least 0.02 pg/mL, in the experimental groups compared to the control group ‐‐ with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention. We expect to find a decrease in cancer‐related fatigue, as assessed by IL‐6 (interleukin 6) test, with a mean difference of at least 0.02 pg/mL, in the experimental groups compared to the control group ‐‐ with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention. We expect to find a decrease in cancer‐related fatigue, as assessed by the CRP (c‐reactive protein) test, with a mean difference of at least 0.025 pg/mL, in the experimental groups compared to the control group ‐‐ with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention. We expect to find a decrease in cancer‐related fatigue, as assessed by the Interferon‐gamma exam, with a mean difference of at least 0.03 pg/mL, in the experimental groups compared to the control group ‐‐ with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention. SECONDARY OUTCOME: An improvement in health‐related quality of life, as assessed by the FACT‐G scale, is expected to be found within a difference of 10%, in the experimental groups compared to the control group ‐‐ with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention. It is expected to find a decrease in adverse reactions, assessed by the CTCAE questionnaire items vomiting, nausea, myalgia, fatigue and insomnia, with a 15% difference, in the experimental groups compared to the control group ‐‐ with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention. It is expected to find a decrease in emotional symptoms, assessed by the HADS scale, with a difference of 10%, in the experimental groups compared to the control group ‐‐ with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention. INCLUSION CRITERIA: Women. Age 18 years or more. Auditory and cognitivelly able to understand the study and react to auditory stimuli. Diagnosed with initial or locally advanced breast cancer. Referred to adjuvant or neoadjuvant chemotherapy