Colorectal CancerVR BlueNCT04069702
Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer
A study testing VR Blue in people with Colorectal Cancer, run by Duke University at 1 site in United States.
Trial summary
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- VR Blue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 19 Jul 2021
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-85
- a diagnosis of stage IV colorectal cancer
- clinical pain documented in medical chart (>4 on a 0-10 scale) and confirmed on the day of their study appointment (>4 on a 0-10 scale)
- being able to read and speak English
- self-reported normal or corrected to normal vision
- self-reported normal hearing
Who cannot join
- a serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
- a medical condition that contraindicates safe participation in the study (e.g., recent myocardial infarction)
- visual, hearing, or cognitive impairment that will interfere with the patient's ability to engage in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress.
The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.
The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.
Read the detailed description
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. Unfortunately, analgesics are not uniformly effective and often are associated with poorly tolerated side effects (e.g., constipation, nausea, sedation). There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients.
VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress. VR may be particularly likely to positively impact cognitive pathways by changing pain-related cognitions (e.g., decreasing pain catastrophizing, increasing self-efficacy for pain control). VR-based interventions have the potential to alter these negative ways of thinking, and advanced cancer patients with persistent pain and pain-related distress may be particularly likely to benefit.
The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. That study found that exposure to a 30-minute virtual underwater/sea environment (VR Blue) produced significant increases in pain tolerance for thermal pain stimuli compared to control conditions. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.
The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.
The long-term goal of this research is to improve quality of life in advanced colorectal cancer patients by decreasing pain, tension and distress. This project will provide preliminary data that will be used to inform and optimize development of a multi-session VR protocol to be tested in patients with advanced stage colorectal cancer that could be generalizable to other palliative care populations with pain.
- Conditions
- Colorectal Cancer
- Being tested
- VR Blue
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR BlueBehavioural
VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
| Study group | Role | What they receive |
|---|---|---|
| VR Blue | Experimental | VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. Receives: Behavioral: VR Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Assessed by Examining Number of Participants Accrued
Feasibility was assessed by examining number of participants accrued.
Measured: 6 months
Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol
Feasibility will be assessed by examining protocol adherence (>80% adherence to the protocol [defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure])
Measured: 30 minutes
Feasibility, Assessed by Number of Participants With Completed Data
Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)
Measured: 90 minutes
Acceptability Using the Client Satisfaction Questionnaire
This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.
Measured: 90 minutes
Number of Participants With VR Side Effects
Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions
Measured: 30 minutes
Secondary outcomes (6)
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)
Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.
Measured: Pre-, post-VR session, approximately 90 minutes
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale
Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.
Measured: Pre-VR session assessment
Change in Tension as Measured With the Visual Analog Scale (VAS)
Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.
Measured: Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Distress as Measured With the Visual Analog Scale (VAS)
Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.
Measured: Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale
Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.
Measured: Pre- and post-VR session, approximately 90 minutes
Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale
Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.
Measured: Pre- and post-VR session, approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start12 Mar 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Duke 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Palliative Care Research Cooperative Group, National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sarah A Kelleher, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069702
- Sponsor's protocol ID
- Pro00103248
- Other IDs
- U2CNR014637
- Acronym
- VR Blue
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2019
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the NIH data sharing directive, de-identified data from this study will be transferred to the PCRC De-Identified Data Repository located at the University of Colorado. The PCRC fully supports the Final NIH Statement on Sharing Research Data, and will assist all investigators and study personnel to ensure their compliance. Consistent with OMB Circular A-110 and subsequent NIH Grants Policy Statements, the PCRC will provide access to all de-identified data collected as part of PCRC-supported investigations, insofar as access is consistent with IRB/CHR rules, local, state, and Federal laws and regulations, and the HIPAA Privacy Rule.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04069702
- Acronym / sponsor ID
- VR Blue / Pro00103248
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Palliative Care Research Cooperative Group, National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 22 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress.
The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.
The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.
Detailed description
Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. Unfortunately, analgesics are not uniformly effective and often are associated with poorly tolerated side effects (e.g., constipation, nausea, sedation). There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients.
VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress. VR may be particularly likely to positively impact cognitive pathways by changing pain-related cognitions (e.g., decreasing pain catastrophizing, increasing self-efficacy for pain control). VR-based interventions have the potential to alter these negative ways of thinking, and advanced cancer patients with persistent pain and pain-related distress may be particularly likely to benefit.
The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. That study found that exposure to a 30-minute virtual underwater/sea environment (VR Blue) produced significant increases in pain tolerance for thermal pain stimuli compared to control conditions. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.
The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.
The long-term goal of this research is to improve quality of life in advanced colorectal cancer patients by decreasing pain, tension and distress. This project will provide preliminary data that will be used to inform and optimize development of a multi-session VR protocol to be tested in patients with advanced stage colorectal cancer that could be generalizable to other palliative care populations with pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR Blue | Experimental | Behavioral: VR BlueVR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-85
- a diagnosis of stage IV colorectal cancer
- clinical pain documented in medical chart (>4 on a 0-10 scale) and confirmed on the day of their study appointment (>4 on a 0-10 scale)
- being able to read and speak English
- self-reported normal or corrected to normal vision
Key exclusion criteria (3 listed)
- a serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
- a medical condition that contraindicates safe participation in the study (e.g., recent myocardial infarction)
- visual, hearing, or cognitive impairment that will interfere with the patient's ability to engage in the intervention
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 |
|---|---|---|
| VR BlueVR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress. | Behavioural | VR Blue |
Primary outcome
Feasibility, Assessed by Examining Number of Participants Accrued
Time frame: 6 months
Feasibility was assessed by examining number of participants accrued.
Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol
Time frame: 30 minutes
Feasibility will be assessed by examining protocol adherence (>80% adherence to the protocol [defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure])
Feasibility, Assessed by Number of Participants With Completed Data
Time frame: 90 minutes
Feasibility will be assessed by examining completed data (>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)
Acceptability Using the Client Satisfaction Questionnaire
Time frame: 90 minutes
This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.
Number of Participants With VR Side Effects
Time frame: 30 minutes
Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions
6 secondary outcomes
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)
Time frame: Pre-, post-VR session, approximately 90 minutes
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale
Time frame: Pre-VR session assessment
Change in Tension as Measured With the Visual Analog Scale (VAS)
Time frame: Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Distress as Measured With the Visual Analog Scale (VAS)
Time frame: Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.
Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale
Time frame: Pre- and post-VR session, approximately 90 minutes
Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale
Time frame: Pre- and post-VR session, approximately 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. As part of the NIH data sharing directive, de-identified data from this study will be transferred to the PCRC De-Identified Data Repository located at the University of Colorado. The PCRC fully supports the Final NIH Statement on Sharing Research Data, and will assist all investigators and study personnel to ensure their compliance. Consistent with OMB Circular A-110 and subsequent NIH Grants Policy Statements, the PCRC will provide access to all de-identified data collected as part of PCRC-supported investigations, insofar as access is consistent with IRB/CHR rules, local, state, and Federal laws and regulations, and the HIPAA Privacy Rule.
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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.
Sarah A Kelleher, PhD principal investigator
Duke 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 VR Blue in people with Colorectal Cancer, run by Duke 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 6 inclusion and 3 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 10 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2022). 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?
Feasibility, Assessed by Examining Number of Participants Accrued (time frame: 6 months). The study lists 5 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 10 Jul 2023.