Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy (F-Chem)

November 9, 2021 updated by: Prof. Dr. Joscha Reinhard, Dr. Horst Schmidt Klinik GmbH

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Helios Berlin Buch
      • Schwerin, Germany, 19049
        • Helios Kliniken Schwerin GmbH
    • Hessen
      • Wiesbaden, Hessen, Germany, 65199
        • Klinik für Gynäkologie und gynäkologischen Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypnosis / Hypnotherapy
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.
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.
EXPERIMENTAL: Music therapy

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.
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.
PLACEBO_COMPARATOR: Standard therapy
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ZSDS = Zung Self-rating Depression Scale
Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Every three weeks during chemotherapy and one year after last chemotherapy
Quality of life questionnaire - Core30
Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy
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)
Time Frame: Day 1-5 after chemotherapie and before next chemotherapy
Change of questionnaire scores
Day 1-5 after chemotherapie and before next chemotherapy
Fatigue assessment questionnaire (FAQ)
Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Every three weeks during chemotherapy and one year after last chemotherapy
Screening Scale for Taste Alteration (TA)
Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy
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
Time Frame: 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
change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Horst Schmidt Klinik GmbH

Collaborators

Deutsche Gesellschaft für hypnose und hypnotherapie E.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

November 1, 2021

Study Completion (ACTUAL)

November 1, 2021

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gyn F-Chem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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