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

Helio's Health

Status: Terminated

Conditions: Ovary Cancer; Breast Neoplasm

Treatments: Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03740984

Gyn F-Chem

Details and patient eligibility

About

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

Full description

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

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups, including a placebo group

Hypnosis / Hypnotherapy

Experimental group

Description:

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.

Treatment:

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Music therapy

Experimental group

Description:

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.

Treatment:

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Standard therapy

Placebo Comparator group

Description:

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).

Treatment:

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.