Bladder Urothelial Carcinoma In SituPhase 2NCT04496219
Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer
A Phase 2 study testing Acupuncture Therapy, BCG Solution and Best Practice in people with Bladder Urothelial Carcinoma In Situ and Recurrent Bladder Urothelial Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma In Situ, Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8
- What is being tested?
- Acupuncture Therapy, BCG Solution and Best Practice
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 23 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Diagnosis of American Urological Association (AUA) high-risk non-muscle invasive bladder cancer (NMIBC), including high grade (HG) pT1 (invading only the lamina propria of the bladder), recurrent HG pTa (superficial tumors), HG pTa > 3 cm in size or multifocal, any carcinoma in situ, any variant histology, any lymphovascular invasion, and HG prostatic urethral involvement
- Diagnosis with urothelial carcinoma (primary histologic subtype), localized to the bladder, in the absence of nodal or other visceral metastases
- Patients who have been indicated for induction intravesical BCG in shared-decision-making with their primary urologist
- Have not received acupuncture in the previous 3 months
- Access to phone for study contacts
Show all 10Show fewer
- Willing and able to participate in trial activities
- Platelets: 20,000/ uL or greater
- Absolute neutrophil count (ANC): 500 cells/uL or greater
- Able to understand and willing to sign written informed consent in English
Who cannot join
- Subjects who have had intravesical or systemic chemotherapy or radiation therapy for bladder cancer or for other malignancies prior to entering the study
- Subjects who are indicated to receive other intravesical agents or therapies concurrently with BCG will be excluded
- Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node metastases or metastatic disease involving other organs including brain metastases
- Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for BCG
- BCG is contraindicated in:
- Patients who are pregnant or lactating
Show all 21Show fewer
- Patients with active tuberculosis
- Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent disease (e.g. acquired immunodeficiency syndrome [AIDS], lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or immunosuppressive therapy (e.g. corticosteroids, disease-modifying anti-rheumatic drugs [DMARDs])
- Symptomatic urinary tract infection
- Febrile illness
- Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG
- Any previous allergies or severe reactions to BCG
- Not pregnant or trying to become pregnant. Acupuncture points included in the protocol are contraindicated with pregnancy
- Does not have a pacemaker. There is potential of electrostimulation interfering with the operation and function of pacemakers
- Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG. Fluoroquinolone therapy may decrease the efficacy of intravesical BCG. Antibiotic therapy for ongoing treatment of active tuberculosis will decrease the efficacy of intravesical BCG
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded. Acupuncture points included in the protocol are contraindicated with pregnancy and BCG is contraindicated in pregnancy
- Pacemaker. Patients with pacemakers are restricted due to the potential of electrostimulation interfering with a pacemakers operation
- Platelets: < 20,000/ uL. Risk of bleeding with acupuncture
- ANC: < 500 cells/uL. Risk of infection with acupuncture
- Received acupuncture in the previous 3 months. Acupuncture treatment effects persist after a course of treatment, previous exposure to the intervention has the potential to affect the baseline data for treatment and control arms
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer
This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.
ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.
After completion of study, patients are followed up at 1 week.
- Conditions
- Bladder Urothelial Carcinoma In Situ, Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Superficial Bladder Urothelial Carcinoma
- Being tested
- Acupuncture Therapy, BCG Solution, Best Practice, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Urinary Bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TherapyDevice
Also called Acupuncture
Undergo acupuncture therapy
BCG SolutionBiological
Also called Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Given by intravesical injection
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care symptom management
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acupuncture, BCG) | Experimental | Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Receives: Device: Acupuncture Therapy; Biological: BCG Solution; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (BCG, standard of care) | Active comparator | Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. Receives: Device: Acupuncture Therapy; Biological: BCG Solution; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Will be described via qualitative report.
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
Measured: Baseline, up to 1 week after completion of treatment, an average of 7 weeks
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Patient Satisfaction
Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.
Measured: At 3 weeks and after completion of treatment, an average of 7 weeks
Clinic Staff's Responses to Surveys
Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Number of Adverse Events
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Secondary outcomes (4)
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test.
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Bladder and Bowel Symptoms as Self Reported by Patients
Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Measured: From week 1 to week 6 of treatment
Quality of Life: EORTC-QLQ-C30
Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Measured: From week 1 to week 6 of treatment
Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types
Will be compared via Wilcoxon rank sum test.
Measured: Up to 1 week after completion of treatment, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start22 Jan 2021
- Primary completion16 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder Urothelial Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sarah Psutka, Fred Hutchinson Cancer Center
- Investigators
- Sarah P. Psutka, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496219
- Sponsor's protocol ID
- RG1007421
- Other IDs
- P30CA015704, NCI-2020-05021, 10544
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2020
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04496219
- Acronym / sponsor ID
- RG1007421
- Conditions
- Bladder Urothelial Carcinoma In Situ, Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Superficial Bladder Urothelial Carcinoma
- Keywords
- Urinary Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.
ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.
After completion of study, patients are followed up at 1 week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acupuncture, BCG) | Experimental | Device: Acupuncture Therapy, Biological: BCG Solution, Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. |
| Arm II (BCG, standard of care) | Active comparator | Device: Acupuncture Therapy, Biological: BCG Solution, Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- English-speaking
- Diagnosis of American Urological Association (AUA) high-risk non-muscle invasive bladder cancer (NMIBC), including high grade (HG) pT1 (invading only the lamina propria of the bladder), recurrent HG pTa (superficial tumors), HG pTa > 3 cm in size or multifocal, any carcinoma in situ, any variant histology, any lymphovascular invasion, and HG prostatic urethral involvement
- Diagnosis with urothelial carcinoma (primary histologic subtype), localized to the bladder, in the absence of nodal or other visceral metastases
- Patients who have been indicated for induction intravesical BCG in shared-decision-making with their primary urologist
- Have not received acupuncture in the previous 3 months
Key exclusion criteria (21 listed)
- Subjects who have had intravesical or systemic chemotherapy or radiation therapy for bladder cancer or for other malignancies prior to entering the study
- Subjects who are indicated to receive other intravesical agents or therapies concurrently with BCG will be excluded
- Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node metastases or metastatic disease involving other organs including brain metastases
- Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for BCG
- BCG is contraindicated in:
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 |
|---|---|---|
| Acupuncture TherapyAlso: AcupunctureUndergo acupuncture therapy | Device | Arm I (acupuncture, BCG), Arm II (BCG, standard of care) |
| BCG SolutionAlso: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG SolutionGiven by intravesical injection | Biological | Arm I (acupuncture, BCG), Arm II (BCG, standard of care) |
| Best PracticeAlso: standard of care, standard therapyReceive standard of care symptom management | Other | Arm I (acupuncture, BCG), Arm II (BCG, standard of care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (acupuncture, BCG), Arm II (BCG, standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (acupuncture, BCG), Arm II (BCG, standard of care) |
Primary outcome
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Will be described via qualitative report.
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Time frame: Baseline, up to 1 week after completion of treatment, an average of 7 weeks
Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.
Patient Satisfaction
Time frame: At 3 weeks and after completion of treatment, an average of 7 weeks
Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.
Clinic Staff's Responses to Surveys
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report
Number of Adverse Events
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
4 secondary outcomes
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Bladder and Bowel Symptoms as Self Reported by Patients
Time frame: From week 1 to week 6 of treatment
Quality of Life: EORTC-QLQ-C30
Time frame: From week 1 to week 6 of treatment
Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bladder Urothelial Carcinoma In Situ
Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 1
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
RecruitingPhase 3
Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer
Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingObservational study
Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis
Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma
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.
Sarah P. Psutka principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture Therapy, BCG Solution and Best Practice in people with Bladder Urothelial Carcinoma In Situ and Recurrent Bladder Urothelial Carcinoma, run by Fred Hutchinson Cancer Center 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 10 inclusion and 21 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 2 Jan 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled (time frame: Up to 1 week after completion of treatment, an average of 7 weeks). The study lists 6 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 2 Jan 2024.