Breast CancerNCT01570218
Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
A study testing Music therapy in people with Breast Cancer and Uterine Cancer, run by Universidade Federal de Goias at 2 sites in Brazil.
Trial summary
OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Breast Cancer, Uterine Cancer, Ovarian Cancer
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2010to Feb 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast and gynecological cancer with indication for radiotherapy
- Performance status 0,1
Who cannot join
- Hemoglobin < 10mg/dl
- Patients in psychotherapy during the study
- Use of antidepressants
- Patients presenting more than one cancer type
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Goias Anticancer Association
Goiânia, Goiás, 74605070
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605070
About this study
Official title: Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.
OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.
Read the detailed description
METHODS: This is a randomized controled study (Control Group - CG e musicotherapy Group - MTG) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments Functional Assessment of Cancer Therapy: Fatigue (FACT-F), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) in three different moments (during first week of radiotherapy, in the intermediate phase's week and during the last week of radiotherapy) for patients of both groups. Women allocated in MTG, in addition to the scales described above, answered the musicotherapy Questionary (MQ), and the Subjective Impression of the Subject's Questionary in last meeting. Musicotherapy sessions were individual and lasted an average of 40 minutes. Music therapeutic techniques used were Musical Audition (MA) and Therapeutic Musical Audition (TMA).
- Conditions
- Breast Cancer, Uterine Cancer, Ovarian Cancer
- Being tested
- Music therapy
- Keywords
- breast cancer, gynecological cancer, radiotherapy, fatigue, musicotherapy
- Medical subject headings
- Breast Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Also called musictherapy
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days. Receives: Behavioral: Music therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the influence of musicotherapy in the reduction of fatigue
To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment.
Measured: 45 days
Secondary outcomes (3)
Assess the reduction of depression
To compare the levels of depression of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Measured: 45 days
Asses the reduction of anxiety
To compare the levels of anxiety of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Measured: 45 days
Assess the quality of life
To compare the levels of quality of life of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Associaçao de Combate ao Cancer em Goias
- Responsible party
- Principal investigator, Ruffo Freitas-Junior, Universidade Federal de Goias
- Investigators
- Ruffo Freitas-Junior, PhD, Study chair, Universidade Federal de GoiasTereza R Alcantara-Silva, Ms Mus, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570218
- Sponsor's protocol ID
- RGM-02
- Status last verified
- May 2018
- First submitted
- 17 Mar 2012
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.
- ClinicalTrials.gov ID
- NCT01570218
- Acronym / sponsor ID
- RGM-02
- Conditions
- Breast Cancer, Uterine Cancer, Ovarian Cancer
- Keywords
- breast cancer, gynecological cancer, radiotherapy, fatigue, musicotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Associaçao de Combate ao Cancer em Goias
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Apr 2012 (estimated)
- 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.
OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.
Detailed description
METHODS: This is a randomized controled study (Control Group - CG e musicotherapy Group - MTG) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments Functional Assessment of Cancer Therapy: Fatigue (FACT-F), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) in three different moments (during first week of radiotherapy, in the intermediate phase's week and during the last week of radiotherapy) for patients of both groups. Women allocated in MTG, in addition to the scales described above, answered the musicotherapy Questionary (MQ), and the Subjective Impression of the Subject's Questionary in last meeting. Musicotherapy sessions were individual and lasted an average of 40 minutes. Music therapeutic techniques used were Musical Audition (MA) and Therapeutic Musical Audition (TMA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Behavioral: Music therapyMusic therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days. |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with breast and gynecological cancer with indication for radiotherapy
- Performance status 0,1
Key exclusion criteria (4 listed)
- Hemoglobin < 10mg/dl
- Patients in psychotherapy during the study
- Use of antidepressants
- Patients presenting more than one cancer type
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 |
|---|---|---|
| Music therapyAlso: musictherapyMusic therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days | Behavioural | Music therapy |
Primary outcome
Assess the influence of musicotherapy in the reduction of fatigue
Time frame: 45 days
To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment.
3 secondary outcomes
Assess the reduction of depression
Time frame: 45 days
Asses the reduction of anxiety
Time frame: 45 days
Assess the quality of life
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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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.
Ruffo Freitas-Junior, PhD study chair
Universidade Federal de Goias
Tereza R Alcantara-Silva, Ms Mus principal investigator
Universidade Federal de Goias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Breast Cancer and Uterine Cancer, run by Universidade Federal de Goias at 2 sites in Brazil.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the influence of musicotherapy in the reduction of fatigue (time frame: 45 days). 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 4 May 2018.