Post-operative Breast CancerNCT06091696
The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery
A study testing inspiratory muscle training and Aerobic exercises in people with Post-operative Breast Cancer, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Post-operative Breast Cancer
- What is being tested?
- inspiratory muscle training and Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Oct 2023to 1 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-operative breast cancer female patients
- Age ≥40 years
- All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
- Having to undergo primary treatment with surgery
Who cannot join
- Severe anemia (Hb ≤ 8 g/dL)
- Presence of underlying chronic cardiac or respiratory disease
- severe infection, neurologic or muscular diseases prohibiting physical activity
- uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
- Contraindications descriped by the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial
This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.
Read the detailed description
Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.
Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.
For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.
This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.
- Conditions
- Post-operative Breast Cancer
- Being tested
- inspiratory muscle training, Aerobic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
inspiratory muscle training will be done by using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). By using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity.
Aerobic exercisesOther
Also called exercises
Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Inspiratory muscle training will be conducted using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). Using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity. Patients will start training with a maximum inspiratory pressure (MIP) of 40%. The training intensity will be adjusted every week based on the MIP measurement. Receives: Other: inspiratory muscle training; Other: Aerobic exercises |
| control group | Active comparator | 5 minutes of warming up and a similar time for cooling down in addition to light aerobic activity will be performed by the patients in both groups. Aerobic exercise training will be done through selected activities for 30 minutes /3 times per week for 8 weeks. Receives: Other: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Measured: at baseline
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Measured: after the end of the treatment (after 8 weeks)
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Measured: at follow up (3 months after the end of the treatment)
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Measured: baseline
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Measured: after the end of the treatment (after 8 weeks)
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Measured: at follow up (3 months after the end of the treatment)
Handgrip strength
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Measured: at baseline
Handgrip strength
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Measured: after the end of the treatment (after 8 weeks)
Handgrip strength
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Measured: at follow up (3 months after the end of the treatment)
Fatigue Assessment Scale (FAS)
The Fatigue assessment scale (FAS) is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Measured: baseline
Fatigue Assessment Scale (FAS)
The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Measured: after the end of the treatment (after 8 weeks)
Fatigue Assessment Scale (FAS)
The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Measured: at follow up (3 months after the end of the treatment)
Perceived stress (Perceived Stress Scale pss 10)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
Measured: baseline
Perceived stress (Perceived Stress Scale pss 10)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
Measured: after the end of the treatment (after 8 weeks)
Perceived stress (Perceived Stress Scale pss 10)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
Measured: at follow up (3 months after the end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start17 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative 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
- a parallel model with 2 groups of study and control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelmoniem Ibrahim, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091696
- Sponsor's protocol ID
- H-2023-367
- Status last verified
- May 2024
- First submitted
- 14 Oct 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request from the funder with a reasonable need
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06091696
- Acronym / sponsor ID
- H-2023-367
- Conditions
- Post-operative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 19 Oct 2023 (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.
This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.
Detailed description
Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.
Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.
For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.
This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a parallel model with 2 groups of study and control.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: inspiratory muscle training, Other: Aerobic exercisesInspiratory muscle training will be conducted using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). Using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity. Patients will start training with a maximum inspiratory pressure (MIP) of 40%. The training intensity will be adjusted every week based on the MIP measurement. |
| control group | Active comparator | Other: Aerobic exercises5 minutes of warming up and a similar time for cooling down in addition to light aerobic activity will be performed by the patients in both groups. Aerobic exercise training will be done through selected activities for 30 minutes /3 times per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-operative breast cancer female patients
- Age ≥40 years
- All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
- Having to undergo primary treatment with surgery
Key exclusion criteria (5 listed)
- Severe anemia (Hb ≤ 8 g/dL)
- Presence of underlying chronic cardiac or respiratory disease
- severe infection, neurologic or muscular diseases prohibiting physical activity
- uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
- Contraindications descriped by the physician
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 |
|---|---|---|
| inspiratory muscle traininginspiratory muscle training will be done by using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). By using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity. | Other | study group |
| Aerobic exercisesAlso: exercisesExercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE). | Other | control group, study group |
Primary outcome
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Time frame: at baseline
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Time frame: after the end of the treatment (after 8 weeks)
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Inspiratory muscle strength by Maximal inspiratory pressure MIP
Time frame: at follow up (3 months after the end of the treatment)
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
Time frame: baseline
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
Time frame: after the end of the treatment (after 8 weeks)
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
Time frame: at follow up (3 months after the end of the treatment)
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Handgrip strength
Time frame: at baseline
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Handgrip strength
Time frame: after the end of the treatment (after 8 weeks)
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Handgrip strength
Time frame: at follow up (3 months after the end of the treatment)
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Fatigue Assessment Scale (FAS)
Time frame: baseline
The Fatigue assessment scale (FAS) is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Fatigue Assessment Scale (FAS)
Time frame: after the end of the treatment (after 8 weeks)
The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Fatigue Assessment Scale (FAS)
Time frame: at follow up (3 months after the end of the treatment)
The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Perceived stress (Perceived Stress Scale pss 10)
Time frame: baseline
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
Perceived stress (Perceived Stress Scale pss 10)
Time frame: after the end of the treatment (after 8 weeks)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
Perceived stress (Perceived Stress Scale pss 10)
Time frame: at follow up (3 months after the end of the treatment)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
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 13 May 2024.
- Individual participant dataSharing planned: Yes. upon request from the funder with a reasonable need
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and Aerobic exercises in people with Post-operative Breast Cancer, run by University of Hail at 1 site in Saudi Arabia.
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 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 13 May 2024. 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 Saudi Arabia. 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?
Inspiratory muscle strength by Maximal inspiratory pressure MIP (time frame: at baseline). The study lists 15 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 13 May 2024.