Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

Breast Neoplasm Clinical Trial

— F-Chem  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03740984
• Other study ID #: Gyn F-Chem
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Ovarian Neoplasms
• Ovary Cancer

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.

Locations

Country	Name	City	State
Germany	Helios Berlin Buch	Berlin
Germany	Helios Kliniken Schwerin GmbH	Schwerin
Germany	Klinik für Gynäkologie und gynäkologischen Onkologie	Wiesbaden	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH	Deutsche Gesellschaft für hypnose und hypnotherapie E.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ZSDS = Zung Self-rating Depression Scale	Change of questionnaire scores	Every three weeks during chemotherapy and one year after last chemotherapy
Primary	Quality of life questionnaire - Core30	Change of questionnaire scores	Every three weeks during chemotherapy and one year after last chemotherapy
Primary	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
Primary	Fatigue assessment questionnaire (FAQ)	Change of questionnaire scores	Every three weeks during chemotherapy and one year after last chemotherapy
Primary	Screening Scale for Taste Alteration (TA)	Change of questionnaire scores	Every three weeks during chemotherapy and one year after last chemotherapy
Secondary	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