Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

Study Overview
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Brief Summary
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Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.

Detailed Description
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Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.

Official Title
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Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial

Conditions
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Breast Neoplasm, Ovary Cancer

Intervention / Treatment
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* Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no previous chemotherapy compliance of the patient to fill out questionnaires informed consent and signed forms histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm) One of following chemotherapy regime: 4x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21->12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-> 12 carboplatin, paclitaxel Exclusion Criteria: does not understand the German language psychosis not able to sign consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis / Hypnotherapy<br>Hypnosis intervention has been created by a certified hypnosis therapist (Prof. Reinhard) has been audio-recorded. The hypnosis intervention is based on the patient's happy place as well as many other interventions which all focus on support and wellbeing (total recording time ca. 4 ½ hours). All patients are advice to start with the beginning, however during the course of chemotherapy they are allowed to skip mp3 files, if they prefer to listen to a new intervention. | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.<br>* During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.<br>|
| Experimental: Music therapy<br>For the music therapy the following music recordings have been used. All patients were allowed to skip tracks if they did not like to listen to that particular track. Purple Waves - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Black Garden View - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Sunset Destination - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Crystal Tree - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Best nature sounds / Ocean Volume 2 - Best Relaxation Music - Deep Sleep Top 10 Serse: Aria Ombra mai Fu - Andreas Scholl, Akademie für Alte music Berlin - Händel Johann Sebastian Bach: Jesus Bleibet Meine Freude (Studio) - Eduard Stan - Piano Recital Mozart: Concerto pour violon no 4 en re majeur, KV (Köchel listing) 218 - Christian Ferras; Pietro Argento; Orchestra Scarlatti di Nap - La fete a Stradivarius ... etc. | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.<br>* During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.<br>|
| Placebo Comparator: Standard therapy<br>In this standard therapy the patient listens to a short explanation that they were randomized into the control arm and that they are allowed to listen to silence (tracks with no music or intervention). | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.<br>* During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ZSDS = Zung Self-rating Depression Scale | Change of questionnaire scores | Every three weeks during chemotherapy and one year after last chemotherapy | 
| Quality of life questionnaire - Core30 | Change of questionnaire scores | Every three weeks during chemotherapy and one year after last chemotherapy | 
| Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire) | Change of questionnaire scores | Day 1-5 after chemotherapie and before next chemotherapy | 
| Fatigue assessment questionnaire (FAQ) | Change of questionnaire scores | Every three weeks during chemotherapy and one year after last chemotherapy | 
| Screening Scale for Taste Alteration (TA) | Change of questionnaire scores | Every three weeks during chemotherapy and one year after last chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate | Long term ECG recording before and during chemotherapy | change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Side effects of chemotherapy