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Funding withdrawn from sponsor.
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| Name | Class |
|---|---|
| Deutsche Gesellschaft für hypnose und hypnotherapie E.V. | UNKNOWN |
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Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.
Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis / Hypnotherapy | Experimental | 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. |
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| Music therapy | Experimental | 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. |
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| Standard therapy | Placebo Comparator | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. | Other | 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. |
| 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 |
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Gynäkologie und gynäkologischen Onkologie | Wiesbaden | Hesse | 65199 | Germany | ||
| Helios Berlin Buch |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective randomised Trial:
Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
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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).
|
| Berlin |
| 13125 |
| Germany |
| Helios Kliniken Schwerin GmbH | Schwerin | 19049 | Germany |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |