Ovarian CancerFIT4SURGERYNCT05092763
Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer
A study testing FIT4SURGERY in people with Ovarian Cancer and Neoadjuvant Chemotherapy, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Neoadjuvant Chemotherapy, Prehabilitation
- What is being tested?
- FIT4SURGERY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 31 Oct 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female; ≥ 60 years of age
- Diagnosed with ovarian, fallopian tube or primary peritoneal cancer and undergoing planned neoadjuvant chemotherapy and are expecting to undergo planned surgery
- Fluent in spoken and written English
- Own a smartphone
- Have access to the internet to complete assessments
Who cannot join
- Patients receiving planned chemotherapy only
- Patients with uncontrolled cardiovascular disease, who are non-ambulatory, or who have severe cognitive or functional limitations precluding their ability to participate in a physical activity intervention
- Pregnant women or prisoners
- Patients whose oncologist has not provided clearance for their participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer (FIT4SURGERY)
The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.
Read the detailed description
Ovarian cancer is the deadliest gynecologic cancer with 5-year survival rates of approximately 48%. Standard of care treatment is grueling, requiring a radical "debulking" surgery and 5 months of chemotherapy. Cytoreductive surgery for ovarian cancer is often extensive, due to the necessary removal of all visible cancer. This radical surgery results in major postoperative complication rates as high as 50% in prospective clinical trials, and 75% occur within 2 weeks of surgery. Half of women are greater than 60 years-old and have high rates of hospital readmission and postoperative complications. Aside from immediate morbidity and mortality related to surgery itself, postoperative complications, such as anastomotic leak, sepsis, or pelvic abscess, can delay the onset of adjuvant chemotherapy, resulting in decreased survival. These postoperative complications also lead to increased discharge to a non-home setting, decreased quality of life, increased costs, and mortality.
Although all patients with ovarian cancer undergo this treatment schedule, older women are at particularly high risk for adverse events. Among women with ovarian cancer, more than 50% are over the age of 60 and up to 40% of these older women are defined as frail. Both age and frailty have been shown to be independent predictors of surgical complications, chemotherapy complications, as well as under-treatment with chemotherapy, resulting in inferior cancer-specific survival. Additionally, the definition of aging contains mechanisms beyond the chronological age of the patient. Both a cancer diagnosis and receipt of chemotherapy lead to synergistic biologic and physiologic changes that accelerate aging and increase frailty. Many older women with ovarian cancer are treated with neoadjuvant chemotherapy which is delivered in 3-4 cycles prior to surgery and this time period provides an optimal window to intervene to improve high-risk older patients' surgical outcomes.
Prehabilitation is the process of enhancing an individual's functional capacity prior to a forthcoming stressor, such as a major surgery, with the goal of improving postoperative outcomes. Prehabilitation programs are multimodal and can involve medical optimization, preoperative physical exercise, nutritional support and stress/anxiety reduction. Benefits of prehabilitation include reduced length of stay, fewer postoperative complications and improved postoperative pain. Even small increases in light physical activity or reducing sedentary time has been shown to slow or halt functional decline and improve quality of life. Among advanced cancer patients, physical activity interventions have been shown to be safe and feasible. They have also been associated with improved aerobic capacity, increased strength, and increased physical function. These parameters are important in older ovarian cancer patients to prevent functional decline, reduce frailty, and decrease surgical morbidity.
However, not all prehabilitation interventions or physical activity interventions are effective. There are populations that do not have sufficient time prior to surgery to have a meaningful change in activity or nutrition, this is especially true for cancer patients who often have a short window between diagnosis and surgery. Furthermore, many physical activity interventions in the pre-operative period have used structured, in-person, professionally-led programs with high intensity activity that may not be appropriate for the changing symptom burden of older ovarian cancer patients undergoing chemotherapy.
Instead of a one-size fits all approach, the American Cancer Society recommends that patients with advanced cancer engage in physical activity tailored to their capability. A recent systematic review and meta-analysis of prehabilitation in cancer patients undergoing abdominal operations noted that data specific to older patients are sparse. This study seeks to address this critical research gap by testing a home-based, patient-tailored, physical activity prehabilitation program (FIT4SURGERY) among older women with ovarian cancer undergoing neoadjuvant chemotherapy.
Physical activity has been shown to improve functional health and energy balance as well as decrease rates of frailty and sarcopenia, important prognostic factors prior to surgery, especially for older adults, and important prognostic factors for ovarian cancer. Increasing physical activity and motivating behavior change is difficult and many preoperative physical activity interventions have not utilized techniques and frameworks which have been successfully used among patients with chronic diseases. Social cognitive theory (SCT) is a framework which has been successfully used to design physical activity inventions that lead to behavior change. SCT has three main components, self-monitoring, self-judgment and self-evaluation which all contribute to self-regulation which is ultimately what drives behavior change. Behavioral interventions using SCT frameworks have been studied in healthy participants including cancer survivors, and have been shown to increase physical activity. Among women with metastatic breast cancer undergoing chemotherapy, an mHealth behavioral physical activity intervention consisting of a wearable activity tracker to provide direct feedback and a mobile app with motivational messaging, has been implemented by our research group. This study examines a modified version of this intervention, as prehabilitation, for the older ovarian cancer patient, as SCT-driven physical activity interventions have not been studied in a preoperative population.
Compared to the gold standard of professionally led, physical activity interventions, interventions via phone and email have been shown to be potentially as effective as more resource intensive interventions at increasing physical activity. Interventions using mHealth app-based platforms have also been shown to increase physical activity. Specifically, for older patients with ovarian cancer undergoing chemotherapy, interventions using wearable devices may be useful because they are home-based, easy to use, give immediate feedback, and use technology most patients already own. Caregivers can also be enlisted to help patients; activating social support for physical activity. Wearable devices allow for remote monitoring of participants and prevent the need for in-person visits which may be difficult for patients undergoing chemotherapy particularly during the COVID-19 pandemic. Furthermore, Fit4Surgery incorporates daily reported symptom burden into activity goals as symptoms can wax and wane during treatment. Such a tailored, home-based, patient-specific approach that facilitates the gradual and safe adoption of physical activity that can be supported by caregivers is ideal for older ovarian cancer patients.
- Conditions
- Ovarian Cancer, Neoadjuvant Chemotherapy, Prehabilitation
- Being tested
- FIT4SURGERY, Healthy Lifestyle Control
- Keywords
- ovarian cancer, neoadjuvant chemotherapy, chemotherapy, physical activity, prehabilitation
- Medical subject headings
- Ovarian Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT4SURGERYBehavioural
The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. Patients are asked to wear the Fitbit through the entire 9-12 weeks in which they are receiving neoadjuvant chemotherapy both when asleep and when awake. Patients are taught how to understand the Fitbit outputs on the application, for example, understanding how to monitor their steps and heart rate. Caregivers are also be encouraged to assist patients. Patients are provided with information about the benefits of physical activity and effective behavior change strategies for incorporating physical activity into their daily lives. These include things such as short bouts of activity by walking around the room during commercial breaks or planning to be dropped off a short walk from a destination.
Healthy Lifestyle ControlBehavioural
Participants assigned to this study arm are instructed to go about their usual activities and receive education about physical activity and a healthy lifestyle for ovarian cancer patients. They are encouraged to download the free Cancer.Net mobile app and visit the cancer.net website for educational materials related to ovarian cancer and survivorship. At the end of the 9-12 week intervention, participants in the Healthy Lifestyle group receive a Fitbit for their optional, personal use after surgery.
| Study group | Role | What they receive |
|---|---|---|
| FIT4SURGERY Intervention | Experimental | The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. Receives: Behavioral: FIT4SURGERY |
| Healthy Lifestyle Control | Active comparator | The Healthy Lifestyle Control group engages in their usual activities and receives education about physical activity and a healthy lifestyle for ovarian cancer patients. They receive weekly check in calls. Receives: Behavioral: Healthy Lifestyle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are evaluable for both baseline and post-intervention assessments
Evaluability will be measured for all patients enrolled in the study regardless of intervention assignment. Patients will be considered evaluable if they complete both the pre-intervention baseline assessments (frailty, PROs) and the post-intervention pre-surgery assessments. The proportion of patients evaluable, according to the above definition, over all patients enrolled will be calculated.
Measured: Through study completion, average of 9-12 weeks
Proportion of patients who are adherent to the Fit4Surgery intervention measured among those in the Fit4Surgery arm.
Adherence will be measured in the Fit4Surgery arm. Patients will be considered adherent to the Fit4Surgery intervention if they wear their Fitbit for >70% of the days during the study period (i.e., ~44/63 days) and if they meet their physical activity goals (step count) on >70% of the days during the study period. The proportion of patients in the Fit4Surgery arm who are adherent to the intervention, according to the above definition, will be calculated.
Measured: Through study completion, average of 9-12 weeks
Secondary outcomes (8)
Change in frailty
Frailty will be assessed at baseline and prior to surgery using the "Fried's phenotype method" in patients in both groups. According to this scale, patients will be categorized as non-frail, pre-frail or frail.
Measured: Baseline and once at 9-12 weeks
Change in anxiety
Anxiety will be measured using "PROMIS anxiety short form 7a" measure.
Measured: Baseline and once at 9-12 weeks
Change in physical function
Physical function will be measured using "PROMIS physical function short form 10a" measure.
Measured: Baseline and once at 9-12 weeks
Change in fatigue
Fatigue will be measured using "PROMIS fatigue short form 7a" measure.
Measured: Baseline and once at 9-12 weeks
Adverse Events
The number of adverse events will be recorded and graded according to CTCAE v5.0.
Measured: Once at 9-12 weeks
Surgical Complications
Medical record review will be performed to examine postoperative complications which will be graded using the Clavien-Dindo scale.
Measured: 90 days post surgery
Progression free survival
Medical records will be reviewed for up to three years to monitor for cancer recurrence.
Measured: three years post surgery
Overall survival
Medical records will be reviewed for up to three years to monitor for overall survival.
Measured: three years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start10 Dec 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Barber, Northwestern University
- Investigators
- Emma Barber, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092763
- Sponsor's protocol ID
- STU00215518
- Acronym
- FIT4SURGERY
- Status last verified
- Apr 2025
- First submitted
- 13 Aug 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer (FIT4SURGERY)
- ClinicalTrials.gov ID
- NCT05092763
- Acronym / sponsor ID
- FIT4SURGERY / STU00215518
- Conditions
- Ovarian Cancer, Neoadjuvant Chemotherapy, Prehabilitation
- Keywords
- ovarian cancer, neoadjuvant chemotherapy, chemotherapy, physical activity, prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 26 Oct 2021 (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 purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.
Detailed description
Ovarian cancer is the deadliest gynecologic cancer with 5-year survival rates of approximately 48%. Standard of care treatment is grueling, requiring a radical "debulking" surgery and 5 months of chemotherapy. Cytoreductive surgery for ovarian cancer is often extensive, due to the necessary removal of all visible cancer. This radical surgery results in major postoperative complication rates as high as 50% in prospective clinical trials, and 75% occur within 2 weeks of surgery. Half of women are greater than 60 years-old and have high rates of hospital readmission and postoperative complications. Aside from immediate morbidity and mortality related to surgery itself, postoperative complications, such as anastomotic leak, sepsis, or pelvic abscess, can delay the onset of adjuvant chemotherapy, resulting in decreased survival. These postoperative complications also lead to increased discharge to a non-home setting, decreased quality of life, increased costs, and mortality.
Although all patients with ovarian cancer undergo this treatment schedule, older women are at particularly high risk for adverse events. Among women with ovarian cancer, more than 50% are over the age of 60 and up to 40% of these older women are defined as frail. Both age and frailty have been shown to be independent predictors of surgical complications, chemotherapy complications, as well as under-treatment with chemotherapy, resulting in inferior cancer-specific survival. Additionally, the definition of aging contains mechanisms beyond the chronological age of the patient. Both a cancer diagnosis and receipt of chemotherapy lead to synergistic biologic and physiologic changes that accelerate aging and increase frailty. Many older women with ovarian cancer are treated with neoadjuvant chemotherapy which is delivered in 3-4 cycles prior to surgery and this time period provides an optimal window to intervene to improve high-risk older patients' surgical outcomes.
Prehabilitation is the process of enhancing an individual's functional capacity prior to a forthcoming stressor, such as a major surgery, with the goal of improving postoperative outcomes. Prehabilitation programs are multimodal and can involve medical optimization, preoperative physical exercise, nutritional support and stress/anxiety reduction. Benefits of prehabilitation include reduced length of stay, fewer postoperative complications and improved postoperative pain. Even small increases in light physical activity or reducing sedentary time has been shown to slow or halt functional decline and improve quality of life. Among advanced cancer patients, physical activity interventions have been shown to be safe and feasible. They have also been associated with improved aerobic capacity, increased strength, and increased physical function. These parameters are important in older ovarian cancer patients to prevent functional decline, reduce frailty, and decrease surgical morbidity.
However, not all prehabilitation interventions or physical activity interventions are effective. There are populations that do not have sufficient time prior to surgery to have a meaningful change in activity or nutrition, this is especially true for cancer patients who often have a short window between diagnosis and surgery. Furthermore, many physical activity interventions in the pre-operative period have used structured, in-person, professionally-led programs with high intensity activity that may not be appropriate for the changing symptom burden of older ovarian cancer patients undergoing chemotherapy.
Instead of a one-size fits all approach, the American Cancer Society recommends that patients with advanced cancer engage in physical activity tailored to their capability. A recent systematic review and meta-analysis of prehabilitation in cancer patients undergoing abdominal operations noted that data specific to older patients are sparse. This study seeks to address this critical research gap by testing a home-based, patient-tailored, physical activity prehabilitation program (FIT4SURGERY) among older women with ovarian cancer undergoing neoadjuvant chemotherapy.
Physical activity has been shown to improve functional health and energy balance as well as decrease rates of frailty and sarcopenia, important prognostic factors prior to surgery, especially for older adults, and important prognostic factors for ovarian cancer. Increasing physical activity and motivating behavior change is difficult and many preoperative physical activity interventions have not utilized techniques and frameworks which have been successfully used among patients with chronic diseases. Social cognitive theory (SCT) is a framework which has been successfully used to design physical activity inventions that lead to behavior change. SCT has three main components, self-monitoring, self-judgment and self-evaluation which all contribute to self-regulation which is ultimately what drives behavior change. Behavioral interventions using SCT frameworks have been studied in healthy participants including cancer survivors, and have been shown to increase physical activity. Among women with metastatic breast cancer undergoing chemotherapy, an mHealth behavioral physical activity intervention consisting of a wearable activity tracker to provide direct feedback and a mobile app with motivational messaging, has been implemented by our research group. This study examines a modified version of this intervention, as prehabilitation, for the older ovarian cancer patient, as SCT-driven physical activity interventions have not been studied in a preoperative population.
Compared to the gold standard of professionally led, physical activity interventions, interventions via phone and email have been shown to be potentially as effective as more resource intensive interventions at increasing physical activity. Interventions using mHealth app-based platforms have also been shown to increase physical activity. Specifically, for older patients with ovarian cancer undergoing chemotherapy, interventions using wearable devices may be useful because they are home-based, easy to use, give immediate feedback, and use technology most patients already own. Caregivers can also be enlisted to help patients; activating social support for physical activity. Wearable devices allow for remote monitoring of participants and prevent the need for in-person visits which may be difficult for patients undergoing chemotherapy particularly during the COVID-19 pandemic. Furthermore, Fit4Surgery incorporates daily reported symptom burden into activity goals as symptoms can wax and wane during treatment. Such a tailored, home-based, patient-specific approach that facilitates the gradual and safe adoption of physical activity that can be supported by caregivers is ideal for older ovarian cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT4SURGERY Intervention | Experimental | Behavioral: FIT4SURGERYThe Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. |
| Healthy Lifestyle Control | Active comparator | Behavioral: Healthy Lifestyle ControlThe Healthy Lifestyle Control group engages in their usual activities and receives education about physical activity and a healthy lifestyle for ovarian cancer patients. They receive weekly check in calls. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female; ≥ 60 years of age
- Diagnosed with ovarian, fallopian tube or primary peritoneal cancer and undergoing planned neoadjuvant chemotherapy and are expecting to undergo planned surgery
- Fluent in spoken and written English
- Own a smartphone
- Have access to the internet to complete assessments
Key exclusion criteria (4 listed)
- Patients receiving planned chemotherapy only
- Patients with uncontrolled cardiovascular disease, who are non-ambulatory, or who have severe cognitive or functional limitations precluding their ability to participate in a physical activity intervention
- Pregnant women or prisoners
- Patients whose oncologist has not provided clearance for their participation
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 |
|---|---|---|
| FIT4SURGERYThe Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. Patients are asked to wear the Fitbit through the entire 9-12 weeks in which they are receiving neoadjuvant chemotherapy both when asleep and when awake. Patients are taught how to understand the Fitbit outputs on the application, for example, understanding how to monitor their steps and heart rate. Caregivers are also be encouraged to assist patients. Patients are provided with information about the benefits of physical activity and effective behavior change strategies for incorporating physical activity into their daily lives. These include things such as short bouts of activity by walking around the room during commercial breaks or planning to be dropped off a short walk from a destination. | Behavioural | FIT4SURGERY Intervention |
| Healthy Lifestyle ControlParticipants assigned to this study arm are instructed to go about their usual activities and receive education about physical activity and a healthy lifestyle for ovarian cancer patients. They are encouraged to download the free Cancer.Net mobile app and visit the cancer.net website for educational materials related to ovarian cancer and survivorship. At the end of the 9-12 week intervention, participants in the Healthy Lifestyle group receive a Fitbit for their optional, personal use after surgery. | Behavioural | Healthy Lifestyle Control |
Primary outcome
Proportion of patients who are evaluable for both baseline and post-intervention assessments
Time frame: Through study completion, average of 9-12 weeks
Evaluability will be measured for all patients enrolled in the study regardless of intervention assignment. Patients will be considered evaluable if they complete both the pre-intervention baseline assessments (frailty, PROs) and the post-intervention pre-surgery assessments. The proportion of patients evaluable, according to the above definition, over all patients enrolled will be calculated.
Proportion of patients who are adherent to the Fit4Surgery intervention measured among those in the Fit4Surgery arm.
Time frame: Through study completion, average of 9-12 weeks
Adherence will be measured in the Fit4Surgery arm. Patients will be considered adherent to the Fit4Surgery intervention if they wear their Fitbit for >70% of the days during the study period (i.e., ~44/63 days) and if they meet their physical activity goals (step count) on >70% of the days during the study period. The proportion of patients in the Fit4Surgery arm who are adherent to the intervention, according to the above definition, will be calculated.
8 secondary outcomes
Change in frailty
Time frame: Baseline and once at 9-12 weeks
Change in anxiety
Time frame: Baseline and once at 9-12 weeks
Change in physical function
Time frame: Baseline and once at 9-12 weeks
Change in fatigue
Time frame: Baseline and once at 9-12 weeks
Adverse Events
Time frame: Once at 9-12 weeks
Surgical Complications
Time frame: 90 days post surgery
Progression free survival
Time frame: three years post surgery
Overall survival
Time frame: three years post surgery
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 29 Apr 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. This study is not recruiting at the moment.
Emma Barber, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT4SURGERY in people with Ovarian Cancer and Neoadjuvant Chemotherapy, run by Northwestern University at 1 site in United States.
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 5 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 29 Apr 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 United States. 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?
Proportion of patients who are evaluable for both baseline and post-intervention assessments (time frame: Through study completion, average of 9-12 weeks). The study lists 2 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 29 Apr 2025.