Endometrial CancerFIT-ENDONCT07622901
Fasting InTervention for Endometrial Cancer
A study testing Prolonged Overnight Fasting (POF), Blood Specimen Collection and Blood Sugar Monitor in people with Endometrial Cancer, run by University of Miami at 1 site in United States.
Trial summary
The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Prolonged Overnight Fasting (POF), Blood Specimen Collection and Blood Sugar Monitor
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older.
- Able to provide consent.
- Able to read/understand English, Spanish or Haitian Creole.
- Have a diagnosis of Type I (low-grade) endometrial cancer at any stage, histologically confirmed prior to the start of the intervention.
- Planned minimally invasive surgical treatment (laparoscopy or robotic approach to hysterectomy).
- Approval to participate from treating oncologist, confirmed via email or in writing.
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- Eastern Cooperative Oncology Group (ECOG) Performance status grade 0-2.
- Surgeries must be at one of the following institutions:
- Sylvester Comprehensive Cancer Center
- University of Miami Hospital (UHealth) Tower
- Internet access on a smart phone, tablet, or computer.
- Agree to be randomly assigned to any study group.
Who cannot join
- Women less than 18 years of age.
- Unable to provide consent.
- Unable to read/understand English or Spanish.
- History of prior hysterectomy.
- Any contraindication for prolonged overnight fasting of 13 hours or exercising as determined by a physician.
- Engaging in structured fasting consistently (equal to or more than 50% of the time) for >12 hours/night.
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- Presence of a severe medical or psychiatric condition or medication that would preclude participation of the study intervention, unstable cardiac disease.
- Diagnosis of diabetes treated with insulin, metformin, sulfonylureas, or Glucagon-like peptide-1 (GLP-1) agonist medications.
- Recent history of a clinical eating disorder as determined by self-report, medical history, or clinical judgement. Participants with a history of an eating disorder that is well-managed and in sustained remission may be eligible, subject to investigator discretion.
- Women for whom definitive hysterectomy is not planned for treatment of their endometrial cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Grey Freylersythe, BS, 305-243-9832, g.freylersythe@med.miami.edu
Tracy E Crane, PhD, RDN
About this study
Official title: Fasting InTervention for Endometrial Cancer (FIT-ENDO)
The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. These problems can cause inflammation and may help cancer grow or make treatment less effective. Early research shows that fasting overnight might help improve these problems.
- Conditions
- Endometrial Cancer
- Being tested
- Prolonged Overnight Fasting (POF), Blood Specimen Collection, Blood Sugar Monitor, Hysterectomy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Overnight Fasting (POF)Behavioural
Participants will be asked to not consume any calorie-containing food/drinks after 8pm and to fast at least 12 hours nightly, increasing to 14 hours gradually over the course of a week. Participants will be asked to maintain the prolonged overnight fasting (POF) for the duration of the intervention, with modifications as needed in the immediate postsurgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an eJournal through My Wellness Research Patients will enroll and begin the intervention 28 +/- 14 days prior to their scheduled surgery (hysterectomy) and continue for 6 weeks postsurgery.
Blood Specimen CollectionProcedure or surgery
Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
Blood Sugar MonitorOther
Also called Continuous Glucose Monitor (CGM)
Participants in both groups will wear a blood sugar monitor for the duration of their participation on the study, except on the day of surgery. The monitor is worn on the participant's arm and checks the participants blood sugar every 15 minutes.
HysterectomyProcedure or surgery
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Overnight Fasting (POF) Group | Experimental | Participants in this group will begin and be asked to maintain a prolonged overnight fasting (POF) plan for the duration of the intervention, with modifications as needed in the immediate post-surgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an electronic journal (eJournal) through the University of Miami's My Wellness Research app.
Participants will meet with a nutrition health coach weekly by video or phone call. Participants will also under blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessment and quality of life questionnaires.
Total participation duration is about 10 weeks. Receives: Behavioral: Prolonged Overnight Fasting (POF); Procedure: Blood Specimen Collection; Other: Blood Sugar Monitor; Procedure: Hysterectomy |
| Attention Control Group | Other | Participants randomly assigned to this group will receive general health coaching video or telephone calls weekly for the duration of the study (3 weeks prior to surgery to 6 weeks post-surgery). Sessions will last approximately 15-20 minutes each time.
Participants will also undergo blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessments and quality of life questionnaires. At the end of the study, participants will receive a physical activity tracker and study notebooks.
Total participation duration is about 10 weeks. Receives: Procedure: Blood Specimen Collection; Other: Blood Sugar Monitor; Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria
Feasibility of recruitment will reported as the percentage of participants who consent to participate and meet eligibility criteria. Criterion for success: At least (≥) 50% of all eligible participants at Baseline (T0) consent to participate between both arms.
Measured: Baseline
Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points.
Feasibility of retention will be reported as the percentage of participants who adhere to and complete the prolonged overnight fasting (POF) intervention and data collection at all time points. Criterion for success: Greater than (>) 70% of all assigned participants complete the intervention and data collection at all time points (T2).
Measured: Up to 10 weeks
Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention.
Acceptability will be reported as the percentage of participants who report satisfaction with the prolonged overnight fasting (POF) intervention after completion. Criterion for success: Greater than (>) 80% of all assigned participants report satisfaction with the intervention at the time of study completion (T2).
Measured: Up to 10 weeks
Secondary outcomes (9)
Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
Change in metabolic biomarker levels (insulin, glucose, IGF-1, HbA1c) at post-surgery compared to pre-surgery, among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be used to analyze changes in metabolic biomarker levels.
Measured: Baseline, about 28 Days
Fold Change in Concentration of Blood and Serum Metabolomics at Post-Surgery compared to Pre-Surgery in the Intervention Versus Control Group
Fold change in concentration of blood and serum metabolomics (> 450 water-soluble metabolites and 600 lipid-related metabolites) at post-surgery compared to pre-surgery will be reported among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be analyzed using Mass Spectrometry (MS) or Nuclear Magnetic Resonance (NMR). Fold Change (FC) represents the ratio of the average metabolite concentration at post-surgery compared to pre-surgery.
Measured: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire
Change in participant quality of life in both the intervention and control groups as measured by scores on the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire will be reported. PROMIS-29 questionnaire is a 29-item validated measure with seven domains of health, including physical function, anxiety, depression, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities and pain intensity. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). Higher scores represent worse symptoms for symptom-oriented domains (anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance) and better health outcomes for function-oriented domains (physical functioning and ability to participate in social roles and activities).
Measured: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale
Change in participant quality of life in both the intervention and control groups as measured by the Rosenburg Self-Esteem Scale will be reported. The Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report questionnaire measuring global self-worth and self-acceptance. It uses a 4-point Likert scale (strongly agree to strongly disagree), with scores ranging from 0-30 (or 10-40). Scores below 15 indicate low self-esteem. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Measured: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale
Change in participant quality of life in both the intervention and control groups as measured by scores on the Hopwood's Body Image Scale will be reported. The Hopwood's Body Image Scale is a 10-item questionnaire used to measure affective, behavioral, and cognitive body image symptoms. Participants can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Measured: Baseline, about 28 Days
Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index
Change in participant quality of life in both the intervention and control groups as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) questionnaire will be reported. The PSQI is a self-administered questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0 to 21, with higher scores indicating worse sleep quality. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Measured: Baseline, about 28 Days
Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire
Change in participant quality of life in both the intervention and control groups as measured by the Godin Leisure Time Exercise Questionnaire will be reported. The Godin Leisure Time Exercise Questionnaire assesses participants' frequency of leisure activity/exercise (strenuous, moderate or light) for more than 15 minutes during a 7-day period. Higher scores indicate a more active lifestyle. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Measured: Baseline, about 28 Days
Change in Diet Quality and Composition As Measured By Responses on the Automated Self-Administered 24 Hour (ASA-24) Dietary Assessment
Change in participant diet quality, in both the intervention and control groups, as measured by the Automated Self-Administered (ASA-24) dietary assessment questionnaire will be reported. The ASA-24 asks respondents about everything they ate and drank the previous day or in the last 24 hours. Responses collected at baseline (T0) will be compared to responses collected the day of surgery (T1).
Measured: Baseline, about 28 days
Change in Incidence of Symptoms Related to Chemotoxicities and Side Effects from Treatment As Measured By Scores on the PRO-CTCAE Questionnaire
Change in incidence of symptoms related to chemotoxicities and side effects from treatment among study participants on both arm as measured by scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE was developed by the National Cancer Institute (NCI) to assess symptomatic adverse events (AEs) in adult patients receiving cancer therapy. The PRO-CTCAE is a self-administered questionnaire. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Measured: Baseline, about 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start27 Feb 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two treatment groups and remain in their designated group throughout the duration of the study: (1) Prolonged overnight fasting (POF) or (2) Attention Control. Randomization will follow a 2:1 ratio of fasting to control conditions.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Tracy E Crane, PhD, RDN, University of Miami
- Investigators
- Tracy E Crane, PhD, RDN, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622901
- Sponsor's protocol ID
- 20250674
- Acronym
- FIT-ENDO
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2026
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting InTervention for Endometrial Cancer (FIT-ENDO)
- ClinicalTrials.gov ID
- NCT07622901
- Acronym / sponsor ID
- FIT-ENDO / 20250674
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. These problems can cause inflammation and may help cancer grow or make treatment less effective. Early research shows that fasting overnight might help improve these problems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two treatment groups and remain in their designated group throughout the duration of the study: (1) Prolonged overnight fasting (POF) or (2) Attention Control. Randomization will follow a 2:1 ratio of fasting to control conditions.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Overnight Fasting (POF) Group | Experimental | Behavioral: Prolonged Overnight Fasting (POF), Procedure: Blood Specimen Collection, Other: Blood Sugar Monitor, Procedure: HysterectomyParticipants in this group will begin and be asked to maintain a prolonged overnight fasting (POF) plan for the duration of the intervention, with modifications as needed in the immediate post-surgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an electronic journal (eJournal) through the University of Miami's My Wellness Research app. Participants will meet with a nutrition health coach weekly by video or phone call. Participants will also under blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessment and quality of life questionnaires. Total participation duration is about 10 weeks. |
| Attention Control Group | Other | Procedure: Blood Specimen Collection, Other: Blood Sugar Monitor, Procedure: HysterectomyParticipants randomly assigned to this group will receive general health coaching video or telephone calls weekly for the duration of the study (3 weeks prior to surgery to 6 weeks post-surgery). Sessions will last approximately 15-20 minutes each time. Participants will also undergo blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessments and quality of life questionnaires. At the end of the study, participants will receive a physical activity tracker and study notebooks. Total participation duration is about 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women 18 years of age or older.
- Able to provide consent.
- Able to read/understand English, Spanish or Haitian Creole.
- Have a diagnosis of Type I (low-grade) endometrial cancer at any stage, histologically confirmed prior to the start of the intervention.
- Planned minimally invasive surgical treatment (laparoscopy or robotic approach to hysterectomy).
Key exclusion criteria (10 listed)
- Women less than 18 years of age.
- Unable to provide consent.
- Unable to read/understand English or Spanish.
- History of prior hysterectomy.
- Any contraindication for prolonged overnight fasting of 13 hours or exercising as determined by a 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 |
|---|---|---|
| Prolonged Overnight Fasting (POF)Participants will be asked to not consume any calorie-containing food/drinks after 8pm and to fast at least 12 hours nightly, increasing to 14 hours gradually over the course of a week. Participants will be asked to maintain the prolonged overnight fasting (POF) for the duration of the intervention, with modifications as needed in the immediate postsurgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an eJournal through My Wellness Research Patients will enroll and begin the intervention 28 +/- 14 days prior to their scheduled surgery (hysterectomy) and continue for 6 weeks postsurgery. | Behavioural | Prolonged Overnight Fasting (POF) Group |
| Blood Specimen CollectionBlood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2). | Procedure or surgery | Attention Control Group, Prolonged Overnight Fasting (POF) Group |
| Blood Sugar MonitorAlso: Continuous Glucose Monitor (CGM)Participants in both groups will wear a blood sugar monitor for the duration of their participation on the study, except on the day of surgery. The monitor is worn on the participant's arm and checks the participants blood sugar every 15 minutes. | Other | Attention Control Group, Prolonged Overnight Fasting (POF) Group |
| HysterectomyParticipants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care. | Procedure or surgery | Attention Control Group, Prolonged Overnight Fasting (POF) Group |
Primary outcome
Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria
Time frame: Baseline
Feasibility of recruitment will reported as the percentage of participants who consent to participate and meet eligibility criteria. Criterion for success: At least (≥) 50% of all eligible participants at Baseline (T0) consent to participate between both arms.
Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points.
Time frame: Up to 10 weeks
Feasibility of retention will be reported as the percentage of participants who adhere to and complete the prolonged overnight fasting (POF) intervention and data collection at all time points. Criterion for success: Greater than (>) 70% of all assigned participants complete the intervention and data collection at all time points (T2).
Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention.
Time frame: Up to 10 weeks
Acceptability will be reported as the percentage of participants who report satisfaction with the prolonged overnight fasting (POF) intervention after completion. Criterion for success: Greater than (>) 80% of all assigned participants report satisfaction with the intervention at the time of study completion (T2).
9 secondary outcomes
Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
Time frame: Baseline, about 28 Days
Fold Change in Concentration of Blood and Serum Metabolomics at Post-Surgery compared to Pre-Surgery in the Intervention Versus Control Group
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale
Time frame: Baseline, about 28 Days
Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index
Time frame: Baseline, about 28 Days
Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire
Time frame: Baseline, about 28 Days
Change in Diet Quality and Composition As Measured By Responses on the Automated Self-Administered 24 Hour (ASA-24) Dietary Assessment
Time frame: Baseline, about 28 days
Change in Incidence of Symptoms Related to Chemotoxicities and Side Effects from Treatment As Measured By Scores on the PRO-CTCAE Questionnaire
Time frame: Baseline, about 28 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
Tracy E Crane, PhD, RDN principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Overnight Fasting (POF), Blood Specimen Collection and Blood Sugar Monitor in people with Endometrial Cancer, run by University of Miami 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 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grey E Freylersythe, BS (305-243-9832, g.freylersythe@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria (time frame: Baseline). The study lists 3 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 14 Jul 2026.