Breast CancerNCT04116281
Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery
A study testing Rehabilitation after breast cancer surgery in people with Breast Cancer, run by Universidade Federal de Sao Carlos at 1 site in Chile.
Trial summary
Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Rehabilitation after breast cancer surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChile
- Study dates
- 2 Dec 2019to 25 Feb 2024
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical indication of conservative or removal breast surgery, associated with axillary lymphadenectomy or sentinel lymph node biopsy
- Any type of breast cancer
- Age range over 18 years
Who cannot join
- Breast cancer recurrence;
- Surgical treatment for bilateral breast cancer;
- Presence of lymphedema in the upper limb, measured by means of cirtometry of the upper limb with a measuring tape 14, asymmetries of more than 1.5 cm between the limbs were considered edema;
- Diagnosis of metastases;
- Shoulder pain compatible with shoulder compression symptoms as determined by the positive Hawkins-Kennedy test 30;
- Previous history of surgery and fractures in the upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Possible Sensory, Biomechanical, Cardiorespiratory and Quality of Life Adaptations Associated With Physical Therapy Rehabilitation in the Short and Long Term Postoperative of Breast Cancer
Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.
- Conditions
- Breast Cancer
- Being tested
- Rehabilitation after breast cancer surgery
- Keywords
- Upper limb function, Heart hate variability, Physical therapy, Breast neoplasms, Pressure pain threshold, Perceived pain
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation after breast cancer surgeryOther
All participants are going to receive physical therapy intervention after breast cancer surgery at least removal drenaige. After that, will be randomized in two groups: Group 1 are going to receive a physical therapy program supervised by a physiotherapist; Group 2 are going to receive some instructions about the same program to perfomr at home without supervision. Both groups are going to receive 3 and 6 months of rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Supervised group | Experimental | Supervised group Receives: Other: Rehabilitation after breast cancer surgery |
| No supervised group | Other | Control group Receives: Other: Rehabilitation after breast cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Measured: Three months
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Measured: Six months
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.
Measured: Three months
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.
Measured: Six months
Secondary outcomes (10)
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire of upper limb function during activity daily routine. The questionnaire has 33 questions and each one has 5 posible answers.
Measured: Three months
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire of upper limb function during activity daily routine. The questionnaire has 33 questions and each one has 5 posible answers.
Measured: Six months
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire wich contains 9 preguntas and 10 differente posibilities of answers.
Measured: Three months
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire wich contains 9 questions and 10 different posibilities of answers.
Measured: Six months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.
Measured: Three months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.
Measured: Six months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture
Measured: Three months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture
Measured: Six months
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire of quality of life regarding symptoms of chemotherapy that affects on quality of life perception. The questionnaire has 53 questions and each one has 4 posible answers.
Measured: Three months
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
This outcome will involve data regarding to a questionnaire of quality of life regarding symptoms of chemotherapy that affects on quality of life perception. The questionnaire has 53 questions and each one has 4 posible answers.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start2 Dec 2019
- Primary completion30 May 2020
- Study completion25 Feb 2024 (estimated)
Why it stopped: Pandemic situation
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Leão Ribeiro, Universidade Federal de Sao Carlos
- Investigators
- Ivana L Ribeiro, PhD, Principal investigator, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116281
- Sponsor's protocol ID
- 154/2019
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2019
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Possible Sensory, Biomechanical, Cardiorespiratory and Quality of Life Adaptations Associated With Physical Therapy Rehabilitation in the Short and Long Term Postoperative of Breast Cancer
- ClinicalTrials.gov ID
- NCT04116281
- Acronym / sponsor ID
- 154/2019
- Conditions
- Breast Cancer
- Keywords
- Upper limb function, Heart hate variability, Physical therapy, Breast neoplasms, Pressure pain threshold, Perceived pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pandemic situation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 4 Oct 2019 (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.
Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Supervised group | Experimental | Other: Rehabilitation after breast cancer surgerySupervised group |
| No supervised group | Other | Other: Rehabilitation after breast cancer surgeryControl group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical indication of conservative or removal breast surgery, associated with axillary lymphadenectomy or sentinel lymph node biopsy
- Any type of breast cancer
- Age range over 18 years
Key exclusion criteria (6 listed)
- Breast cancer recurrence;
- Surgical treatment for bilateral breast cancer;
- Presence of lymphedema in the upper limb, measured by means of cirtometry of the upper limb with a measuring tape 14, asymmetries of more than 1.5 cm between the limbs were considered edema;
- Diagnosis of metastases;
- Shoulder pain compatible with shoulder compression symptoms as determined by the positive Hawkins-Kennedy test 30;
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 |
|---|---|---|
| Rehabilitation after breast cancer surgeryAll participants are going to receive physical therapy intervention after breast cancer surgery at least removal drenaige. After that, will be randomized in two groups: Group 1 are going to receive a physical therapy program supervised by a physiotherapist; Group 2 are going to receive some instructions about the same program to perfomr at home without supervision. Both groups are going to receive 3 and 6 months of rehabilitation program. | Other | No supervised group, Supervised group |
Primary outcome
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.
Strength grip of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.
10 secondary outcomes
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
Upper limb functionality of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
Fatigue of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
Cardiopulmonary function of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Three months
Quality of life of breast cancer patients after a physical therapy rehabilitation program following the surgery.
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: Yes
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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.
Ivana L Ribeiro, PhD principal investigator
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation after breast cancer surgery in people with Breast Cancer, run by Universidade Federal de Sao Carlos at 1 site in Chile.
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 3 inclusion and 6 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: paused, as of the sponsor's last update on 12 Jul 2022. 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 Chile. 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?
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?
Pressure pain threshold over the shoulder of breast cancer patients after a physical therapy rehabilitation program following the surgery. (time frame: Three months). The study lists 4 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 12 Jul 2022.