Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

Not Applicable

Terminated

• Conditions: Breast Neoplasm; Ovary Cancer
• Interventions: Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

• Registration Number: NCT03740984
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-11-10
• Study First Posted: 2018-11-14
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis / Hypnotherapy	Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.	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.
Music therapy	Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.	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.
Standard therapy	Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of heart rate	change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy	Long term ECG recording before and during chemotherapy

Trial Locations

Locations (3)

Klinik für Gynäkologie und gynäkologischen Onkologie; 🇩🇪 Wiesbaden, Hessen, Germany

Helios Berlin Buch; 🇩🇪 Berlin, Germany

Helios Kliniken Schwerin GmbH; 🇩🇪 Schwerin, Germany