ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740984
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
Information provided by (Responsible Party):
Prof. Dr. Joscha Reinhard, 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Ovary Cancer Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective randomised Trial:

Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Single blinded. The participant knows which group intervention is being used (music, hypnosis or standard care). This is being told while listening to the Intervention. All care Providers only know which "colour" mp3 player is being used (white, orange or black).
Primary Purpose: Supportive Care
Official Title: Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. ZSDS = Zung Self-rating Depression Scale [ Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy ]
    Change of questionnaire scores

  2. Quality of life questionnaire - Core30 [ Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy ]
    Change of questionnaire scores

  3. 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

  4. Fatigue assessment questionnaire (FAQ) [ Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy ]
    Change of questionnaire scores

  5. Screening Scale for Taste Alteration (TA) [ Time Frame: Every three weeks during chemotherapy and one year after last chemotherapy ]
    Change of questionnaire scores


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740984


Contacts
Contact: Joscha Reinhard, Prof. Dr. MBBS BSc(Hon) +49 611 43-3516 Joscha.reinhard@helios-gesundheit.de
Contact: Stefanie Becht +49 611 43-3234 Stefanie.Becht@helios-gesundheit.de

Locations
Germany
Klinik für Gynäkologie und gynäkologischen Onkologie Recruiting
Wiesbaden, Hessen, Germany, 65199
Contact: Joscha Reinhard         
Helios Berlin Buch Recruiting
Berlin, Germany, 13125
Contact: Christine Mau         
Zentrum für ambulante gynäkologische Onkologie (ZAGO) Recruiting
Krefeld, Germany, 47805
Contact: Songül Uysal         
Helios Kliniken Schwerin GmbH Recruiting
Schwerin, Germany, 19049
Contact: A. Opazo-Saez         
Sponsors and Collaborators
Dr. Horst Schmidt Klinik GmbH
Deutsche Gesellschaft für hypnose und hypnotherapie E.V.

Responsible Party: Prof. Dr. Joscha Reinhard, Principal investigator, Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT03740984     History of Changes
Other Study ID Numbers: Gyn F-Chem
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Joscha Reinhard, Dr. Horst Schmidt Klinik GmbH:
Chemotherapy
Side effects of chemotherapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders