Breast NeoplasmF-ChemNCT03740984
Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy
A study of Breast Neoplasm and Ovary Cancer, run by Dr. Horst Schmidt Klinik GmbH at 3 sites in Germany.
Trial summary
Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Ovary Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Feb 2018to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- does not understand the German language
- psychosis
- not able to sign consent form
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Helios Berlin Buch
Berlin, 13125
Helios Kliniken Schwerin GmbH
Schwerin, 19049
Klinik für Gynäkologie und gynäkologischen Onkologie
Wiesbaden, Hesse, 65199
About this study
Official title: Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.
Read the detailed description
Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.
- Conditions
- Breast Neoplasm, Ovary Cancer
- Being tested
- Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
- Keywords
- Chemotherapy, Side effects of chemotherapy
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. |
| 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. Receives: Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. |
| 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). Receives: Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZSDS = Zung Self-rating Depression Scale
Change of questionnaire scores
Measured: Every three weeks during chemotherapy and one year after last chemotherapy
Quality of life questionnaire - Core30
Change of questionnaire scores
Measured: 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
Measured: Day 1-5 after chemotherapie and before next chemotherapy
Fatigue assessment questionnaire (FAQ)
Change of questionnaire scores
Measured: Every three weeks during chemotherapy and one year after last chemotherapy
Screening Scale for Taste Alteration (TA)
Change of questionnaire scores
Measured: Every three weeks during chemotherapy and one year after last chemotherapy
Secondary outcomes (1)
Change of heart rate
Long term ECG recording before and during chemotherapy
Measured: change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Feb 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Why it stopped: Funding withdrawn from sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
- Responsible party
- Principal investigator, Prof. Dr. Joscha Reinhard, Dr. Horst Schmidt Klinik GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740984
- Sponsor's protocol ID
- Gyn F-Chem
- Acronym
- F-Chem
- Status last verified
- Nov 2021
- First submitted
- 16 Sep 2018
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03740984
- Acronym / sponsor ID
- F-Chem / Gyn F-Chem
- Conditions
- Breast Neoplasm, Ovary Cancer
- Keywords
- Chemotherapy, Side effects of chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn from sponsor.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
| Arm | Type | Receives |
|---|---|---|
| Hypnosis / Hypnotherapy | Experimental | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.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. |
| Music therapy | Experimental | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.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. |
| Standard therapy | Placebo comparator | Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- does not understand the German language
- psychosis
- not able to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Hypnosis / Hypnotherapy, Music therapy, Standard therapy |
Primary outcome
ZSDS = Zung Self-rating Depression Scale
Time frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Quality of life questionnaire - Core30
Time frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
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
Fatigue assessment questionnaire (FAQ)
Time frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Screening Scale for Taste Alteration (TA)
Time frame: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
1 secondary outcome
Change of heart rate
Time frame: change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy
Results and safety
The study was stopped early (reason given: Funding withdrawn from sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Neoplasm and Ovary Cancer, run by Dr. Horst Schmidt Klinik GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn from sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ZSDS = Zung Self-rating Depression Scale (time frame: Every three weeks during chemotherapy and one year after last chemotherapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.