Clinical trial NCT03740984: Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy
Official title: Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasm
Ovary Cancer
Keywords: Chemotherapy
Side effects of chemotherapy
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
Collaborators: name: Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
First posted: 2018-11-14
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised Trial:

Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility 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

Primary outcomes:
measure: ZSDS = Zung Self-rating Depression Scale
timeFrame: Every three weeks during chemotherapy and one year after last chemotherapy
measure: Quality of life questionnaire - Core30
timeFrame: Every three weeks during chemotherapy and one year after last chemotherapy
measure: Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire)
timeFrame: Day 1-5 after chemotherapie and before next chemotherapy
measure: Fatigue assessment questionnaire (FAQ)
timeFrame: Every three weeks during chemotherapy and one year after last chemotherapy
measure: Screening Scale for Taste Alteration (TA)
timeFrame: Every three weeks during chemotherapy and one year after last chemotherapy
Secondary outcomes:
measure: Change of heart rate
timeFrame: change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Klinik für Gynäkologie und gynäkologischen Onkologie
state: Hessen
city: Berlin
country: Germany
facility: Helios Berlin Buch
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin GmbH
Study officials:
References: