Breast CancerNCT06215027
The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment
A study testing Dance in people with Breast Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial summary
The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with breast cancer
- undergone surgical resection
- after medical referral for physiotherapy
- and physiotherapeutic assessment
Who cannot join
- patients with another previous oncological diagnosis
- previous neuromuscular diseases
- patients who do not agree to take part in the study
- or the impossibility of carrying out the muscle strength assessment and/or other assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
AC Camargo Cancer Center
São Paulo, 01525-001
Letícia Cardenas, PHD, +5511985742277, leticia.cardenas@accamargo.org.br
About this study
Official title: Os Efeitos da dança Como Recurso terapêutico em Pacientes Com câncer de Mama Submetidas a Tratamento cirúrgico
The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.
Read the detailed description
The hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. Objectives: To evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. Method: This is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. The following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. After 16 weeks, the same variables will be assessed.
- Conditions
- Breast Cancer
- Being tested
- Dance
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
Dance protocol
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | Dance Receives: Other: Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
Shoulder range of motion
Measured: Pre-intervention and after 16 weeks
Secondary outcomes (6)
Overall muscle strength
Dynamometer
Measured: Pre-intervention and after 16 weeks
Fatigue
Brief Fatigue Inventory. The BFI is a scale with 11 points (0 to 10), including a dichotomous question about whether the patient felt tired or fatigued in the last 7 days. For each question, zero is considered ''no fatigue'' and 10 is ''worst fatigue possible,'' except for the dichotomous question that is not scored. Among the other questions, 3 measures the severity of fatigue in the current, daily situations, and in the last 24 hours. Six questions measure the influence of fatigue in general activities, mood, walk, work, relationship with other people, and recreation. The total score is the average of all questions. According to the total score, fatigue is classified as mild (1 to 3 points), moderate (4 to 6 points), and severe (7 to 10 points).
Measured: Pre-intervention and after 16 weeks
respiratory muscle strength
Maximum inspiratory and expiratory pressures (MIP and MEP)
Measured: Pre-intervention and after 16 weeks
Functionality
6 minute walk test (6MWT)
Measured: Pre-intervention and after 16 weeks
Pain intensity
Analogic visual scale. The visual analogue pain scale is a measure of pain intensity that has been widely used in several languages. For pain intensity, the scale is most commonly ranging from "no pain" (score of 0) to "worst pain imaginable" (score of 10). A higher rating indicates greater pain intensity.
Measured: Pre-intervention and after 16 weeks
Quality of life (physical well-being, social and family well-being, emotional well-being, functional well-being)
Functional Assessment of Cancer Therapy-Breast (FACT-B). The FACT-B, version 4, is a multidimensional questionnaire composed of 37 questions divided into five domains that assess different dimensions: physical well-being, social and family well-being, emotional well-being, functional well-being and breast cancer subscale.
Measured: Pre-intervention and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leticia Zumpano Cardenas, AC Camargo Cancer Center
- Investigators
- Letícia Cardenas, PHD, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215027
- Sponsor's protocol ID
- 74502023.7.0000.5432
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Os Efeitos da dança Como Recurso terapêutico em Pacientes Com câncer de Mama Submetidas a Tratamento cirúrgico
- ClinicalTrials.gov ID
- NCT06215027
- Acronym / sponsor ID
- 74502023.7.0000.5432
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Jan 2024 (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.
The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.
Detailed description
The hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. Objectives: To evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. Method: This is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. The following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. After 16 weeks, the same variables will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: DanceDance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients diagnosed with breast cancer
- undergone surgical resection
- after medical referral for physiotherapy
- and physiotherapeutic assessment
Key exclusion criteria (4 listed)
- patients with another previous oncological diagnosis
- previous neuromuscular diseases
- patients who do not agree to take part in the study
- or the impossibility of carrying out the muscle strength assessment and/or other assessments
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 |
|---|---|---|
| DanceDance protocol | Other | Dance |
Primary outcome
ROM
Time frame: Pre-intervention and after 16 weeks
Shoulder range of motion
6 secondary outcomes
Overall muscle strength
Time frame: Pre-intervention and after 16 weeks
Fatigue
Time frame: Pre-intervention and after 16 weeks
respiratory muscle strength
Time frame: Pre-intervention and after 16 weeks
Functionality
Time frame: Pre-intervention and after 16 weeks
Pain intensity
Time frame: Pre-intervention and after 16 weeks
Quality of life (physical well-being, social and family well-being, emotional well-being, functional well-being)
Time frame: Pre-intervention and after 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- 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.
Letícia Cardenas, PHD principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance in people with Breast Cancer, run by AC Camargo Cancer Center at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Letícia Cardenas, PHD (5511985742277, leticia.cardenas@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM (time frame: Pre-intervention and after 16 weeks). 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 28 Jan 2025.