Breast CancerNCT03333993
Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy
A study testing Pilates Exercise and Home exercises in people with Breast Cancer and Adjuvant Radiotherapy, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Adjuvant Radiotherapy
- What is being tested?
- Pilates Exercise and Home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2017to 10 Dec 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older
- Women with indication of adjuvant radiotherapy in the period from March 15, 2017 to May 30, 2019 to be performed exclusively at the Hospital de Cancer III (INCA / HCIII).
Who cannot join
- Women who practice physical activity at least 2 times a week for 1 hour
- Women with previous cancer diagnosis
- Women submitted to immediate breast reconstruction
- Presence of acute infections and orthopedic, neurological, decompensated cardiorespiratory and severe renal dysfunction
- Women who are not able to respond to questionnaires and not to agree to sign the Informed Consent Form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial With Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy
Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant therapies resulted in an estimated increase of 22 million cancer survivors worldwide (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown benefits in the increase of the functional capacity that generates a reduction of effort and decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema, radiodermatitis and depression, in the women with breast cancer and with an indication of adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA). After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). Patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). Patients assigned to the control group will not participate in the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative period. In both groups, patients will be submitted, functional capacity assessment, flexibility assessment, assessment of the presence of lymphedema, and questionnaire application of fatigue, quality of life, level of physical activity and depression. Will be performed a descriptive analysis of the population. Univariate logistic regression will be performed between the outcomes according to the exercise groups and also, for the possible confounding variables. The variables with p<0.20 will be selected for adjustment in the construction of the multiple logistic regression model. Those with p<0.05 and/or with clinical significance will be maintained in the model.
Read the detailed description
After recruitment, women will be randomly assigned to: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). At patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). The Mat Pilates program will be based on group sessions with the supervision of physiotherapists specialized in technique. The groups will consist of a maximum of 4 patients, to achieve the basic principles of the technique that include concentration, control, accuracy and fluidity of movement. Mat Pilates sessions will be held in the physiotherapy gymnasium of Cancer Hospital III / INCA. The Mat Pilates program will be held twice a week and the duration of sessions will be 60 minutes, consisting of 5 minutes of exercises 50 minutes of strengthening exercises with flexibilization of the muscular fibers, where the concentric phase of the movement will be performed at the expiration, followed by 5 minutes of relaxation and stretching. The movements will be carried out slowly and with the maximum of 2 sets of 10 replicates. The Swiss ball and elastic band accessories will be used. The Mat Pilates intensity exercises will be controlled by means of the adapted Borg Scale (0-10), where the perception of the effort will vary from 2 (very light) to 7 (moderate-intense). On days of the week in which the patient will not practice the Mat Pilates program, the usual upper limb exercises will be maintained by the physiotherapists on the first postoperative day at Cancer Hospital III / INCA. Patients allocated to the control group will not participate in the Mat Pilates program, but will be directed to maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative. In both groups, the patients will be submitted, the functional capacity evaluation composed of the Disability Arm, Shoulder and Hand (DASH) questionnaire, flexibility assessment, presence of lymphedema, radiodermatitis and application of the questionnaires International Questionnaire of Physical Activity (IPAQ), Functional Assessment of Cancer Therapy- Fatigue (FACT-F) for Fatigue, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (EORTC QLQ-C30) and specific module EORTC QLQ Breast-23 (EORTC QLQ-BR23) for quality of life, and Geriatric Depression Scale(GDS) for depression at the time of study inclusion and in the follow-up (end of radiotherapy, 30 days and 6 months after end).
- Conditions
- Breast Cancer, Adjuvant Radiotherapy
- Being tested
- Pilates Exercise, Home exercises
- Keywords
- Pilates exercise, Fatigue, Quality of Life
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExerciseOther
Also called Pilates method
The Mat Pilates exercise will be performed twice a week and the duration of the sessions will be 60 minutes, consisting of 5 minutes of warm-up exercises, 50 minutes of strengthening exercises followed by 5 minutes of relaxation and stretching.
Home exercisesOther
Also called Institutional Routine
Exercises for upper limbs according to the institutional routine.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in this group will be submitted to 10 sessions of Mat Pilates exercises, performed twice a week, lasting 60 minutes, for a period of 5 weeks (from the beginning to the end of radiotherapy). The program will consist of group sessions of up to 4 patients, supervised by a specialized physiotherapist. In addition, they will be guided to follow with the home exercises, according to the institutional routine. Receives: Other: Pilates Exercise; Other: Home exercises |
| Control Group | Active comparator | Patients assigned to this group will not participate in the Mat Pilates exercises and will be instructed to maintain the home exercises for upper limbs, guided by physiotherapists in the postoperative period, according to the institutional routine. Receives: Other: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
It will be assessed by FACIT-FATIGUE (Version 4) questionnaire.
Measured: 2 years
Secondary outcomes (5)
Quality of Life in breast cancer
It will be measured by EORTC QLQ - BR23 questionnaire.
Measured: 2 years
Functionality
It will be evaluated by Brazilian DASH questionnaire.
Measured: 2 years
Depression
This outcome will be measured by GDS-15 questionnaire.
Measured: 2 years
Quality of life related to health
It will be measured by EORTC QLQ- C30 questionnaire.
Measured: 2 years
Physical activity level
It will be measured by IPAQ questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Mar 2017
- Primary completion30 May 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Daniele Torres, master, Principal investigator, National Cancer Institute, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333993
- Sponsor's protocol ID
- 64099717.7.0000.5274
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2017
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torres DM, de Menezes Fireman K, Fabro EAN, Thuler LCS, Koifman RJ, Bergmann A, da Silva Santos S. Effectiveness of mat pilates on fatigue in women with breast cancer submitted to adjuvant radiotherapy: randomized controlled clinical trial. Support Care Cancer. 2023 May 30;31(6):362. doi: 10.1007/s00520-023-07824-1.
PubMed 37249715
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial With Mat Pilates in Women With Breast Cancer During Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT03333993
- Acronym / sponsor ID
- 64099717.7.0000.5274
- Conditions
- Breast Cancer, Adjuvant Radiotherapy
- Keywords
- Pilates exercise, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 7 Nov 2017 (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.
Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015). In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant therapies resulted in an estimated increase of 22 million cancer survivors worldwide (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown benefits in the increase of the functional capacity that generates a reduction of effort and decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema, radiodermatitis and depression, in the women with breast cancer and with an indication of adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA). After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). Patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). Patients assigned to the control group will not participate in the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative period. In both groups, patients will be submitted, functional capacity assessment, flexibility assessment, assessment of the presence of lymphedema, and questionnaire application of fatigue, quality of life, level of physical activity and depression. Will be performed a descriptive analysis of the population. Univariate logistic regression will be performed between the outcomes according to the exercise groups and also, for the possible confounding variables. The variables with p<0.20 will be selected for adjustment in the construction of the multiple logistic regression model. Those with p<0.05 and/or with clinical significance will be maintained in the model.
Detailed description
After recruitment, women will be randomly assigned to: Intervention Group (Mat Pilates and usual activities) and Control Group (usual activities). At patients in the intervention group will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to end of adjuvant radiotherapy). The Mat Pilates program will be based on group sessions with the supervision of physiotherapists specialized in technique. The groups will consist of a maximum of 4 patients, to achieve the basic principles of the technique that include concentration, control, accuracy and fluidity of movement. Mat Pilates sessions will be held in the physiotherapy gymnasium of Cancer Hospital III / INCA. The Mat Pilates program will be held twice a week and the duration of sessions will be 60 minutes, consisting of 5 minutes of exercises 50 minutes of strengthening exercises with flexibilization of the muscular fibers, where the concentric phase of the movement will be performed at the expiration, followed by 5 minutes of relaxation and stretching. The movements will be carried out slowly and with the maximum of 2 sets of 10 replicates. The Swiss ball and elastic band accessories will be used. The Mat Pilates intensity exercises will be controlled by means of the adapted Borg Scale (0-10), where the perception of the effort will vary from 2 (very light) to 7 (moderate-intense). On days of the week in which the patient will not practice the Mat Pilates program, the usual upper limb exercises will be maintained by the physiotherapists on the first postoperative day at Cancer Hospital III / INCA. Patients allocated to the control group will not participate in the Mat Pilates program, but will be directed to maintain the usual exercises for upper limbs, guided by physiotherapists in the postoperative. In both groups, the patients will be submitted, the functional capacity evaluation composed of the Disability Arm, Shoulder and Hand (DASH) questionnaire, flexibility assessment, presence of lymphedema, radiodermatitis and application of the questionnaires International Questionnaire of Physical Activity (IPAQ), Functional Assessment of Cancer Therapy- Fatigue (FACT-F) for Fatigue, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (EORTC QLQ-C30) and specific module EORTC QLQ Breast-23 (EORTC QLQ-BR23) for quality of life, and Geriatric Depression Scale(GDS) for depression at the time of study inclusion and in the follow-up (end of radiotherapy, 30 days and 6 months after end).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pilates Exercise, Other: Home exercisesPatients in this group will be submitted to 10 sessions of Mat Pilates exercises, performed twice a week, lasting 60 minutes, for a period of 5 weeks (from the beginning to the end of radiotherapy). The program will consist of group sessions of up to 4 patients, supervised by a specialized physiotherapist. In addition, they will be guided to follow with the home exercises, according to the institutional routine. |
| Control Group | Active comparator | Other: Home exercisesPatients assigned to this group will not participate in the Mat Pilates exercises and will be instructed to maintain the home exercises for upper limbs, guided by physiotherapists in the postoperative period, according to the institutional routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 years and older
- Women with indication of adjuvant radiotherapy in the period from March 15, 2017 to May 30, 2019 to be performed exclusively at the Hospital de Cancer III (INCA / HCIII).
Key exclusion criteria (5 listed)
- Women who practice physical activity at least 2 times a week for 1 hour
- Women with previous cancer diagnosis
- Women submitted to immediate breast reconstruction
- Presence of acute infections and orthopedic, neurological, decompensated cardiorespiratory and severe renal dysfunction
- Women who are not able to respond to questionnaires and not to agree to sign the Informed 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 |
|---|---|---|
| Pilates ExerciseAlso: Pilates methodThe Mat Pilates exercise will be performed twice a week and the duration of the sessions will be 60 minutes, consisting of 5 minutes of warm-up exercises, 50 minutes of strengthening exercises followed by 5 minutes of relaxation and stretching. | Other | Intervention Group |
| Home exercisesAlso: Institutional RoutineExercises for upper limbs according to the institutional routine. | Other | Control Group, Intervention Group |
Primary outcome
Fatigue
Time frame: 2 years
It will be assessed by FACIT-FATIGUE (Version 4) questionnaire.
5 secondary outcomes
Quality of Life in breast cancer
Time frame: 2 years
Functionality
Time frame: 2 years
Depression
Time frame: 2 years
Quality of life related to health
Time frame: 2 years
Physical activity level
Time frame: 2 years
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 15 Apr 2021.
- Derived from this study: PubMed 37249715Torres DM, de Menezes Fireman K, Fabro EAN, Thuler LCS, Koifman RJ, Bergmann A, da Silva Santos S. Effectiveness of mat pilates on fatigue in women with breast cancer submitted to adjuvant radiotherapy: randomized controlled clinical trial. Support Care Cancer. 2023 May 30;31(6):362. doi: 10.1007/s00520-023-07824-1.
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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.
Daniele Torres, master principal investigator
National Cancer Institute, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercise and Home exercises in people with Breast Cancer and Adjuvant Radiotherapy, run by Instituto Nacional de Cancer, Brazil 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 2 inclusion and 5 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 15 Apr 2021. 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?
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?
Fatigue (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333993, which also lists 1 linked publication.
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 15 Apr 2021.