Solid TumorNiCENCT05306509
Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology
A study testing NiCE and Routine PPC in people with Solid Tumor and Hematological Malignancies, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Solid Tumor, Hematological Malignancies
- What is being tested?
- NiCE and Routine PPC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children within eight weeks of initial oncologic diagnosis or within eight weeks of relapse/recurrent disease diagnosis
- Children speaking Chinese
- Children's family caregivers accompanying the child in the hospital (only one family member is eligible to take this role under current hospital policy)
- Children's family caregivers speaking Chinese
- Health care providers who are taking care of the eligible children, including but not limited to physicians, nurses, and social workers
Who cannot join
- Children who, in the opinion of their physician, are not capable mentally or verbally of participating in the survey or interview
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hemotology/Oncology Unit and Surgical Oncology Unit of Children's Hospital of Fudan University
Shanghai, Minhang, 201102
Hongsheng Wang, MD, 8613916453373, honswang@hotmail.com
About this study
Official title: Facilitating Early Integration of Palliative Care in Pediatric Oncology: Development and Implementation of a Nurse-initiated Conversation Program for Pediatric Cancer Patients and Their Families
This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.
Read the detailed description
Early integration of PPC, endorsed by a number of international societies, is well supported by evidence on providing multi-layer relief in children and their families over the course of any life-threatening illness. This study will leverage oncology nurses' role, culturally adapt the well-recognized St. Jude Children's Individualized Care Planning and Coordination (ICPC) Model to develop and evaluate a nurse-initiated conversation program to facilitate early integration of palliative care in pediatric oncology care.
- Conditions
- Solid Tumor, Hematological Malignancies
- Being tested
- NiCE, Routine PPC
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiCEBehavioural
Participants will receive an initial conversation led by a trained senior nurse within eight weeks after initial oncologic diagnosis or relapse/recurrent disease diagnosis, with an introduction to the intervention and learning about the goals, values, hopes, and fears of each patient and family. The PPC team will then follow each patient by ongoing regular conversations (related to the child and family's conditions) led by the same nurse, every 4 weeks for six months, when symptom assessment and management, goal-directed supportive care, team collaboration, and care coordination will be delivered according to the family's needs. Increased PPC involvement, end-of-life care and bereavement care will be involved when necessary. If a participant feels any discomfort or distress during the intervention, a break will be taken until they feel better. If not, the central contact person will come and discussion about the participant's feeling and wiliness to continue the intervention.
Routine PPCOther
Participants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-initiated conversations for early integration of palliative care (NiCE) | Experimental | Participants will receive nurse-initiated conversations facilitating early integration of palliative care in pediatric oncology. Receives: Behavioral: NiCE |
| Routine PPC | Other | Participants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment. Receives: Other: Routine PPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of children's quality of life
Scores of children's quality of life will be measured by Peds Quality of Life TM4.0 scale. It encompasses four subscales: physical, emotional, social and school functioning. It asks how much of a problem each item has been during the past month. It comprised of parallel child self-report and parent proxy-report formats. Child self-report includes ages 5-7 years (young child), ages 8-12 years (child), and ages 13-18 years (adolescent). All items use a five-point Likert response set range from 'never' to 'almost always'. Items are reverse-scored and linear-early transformed to a scale of 0 to 100 (0 = 100, 1= 75, 2= 50, 3= 25, 4=0), so that higher scores indicate a better quality of life. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
Measured: Measured every three months over six months.
Secondary outcomes (9)
Incidence of adverse events
Incidence of adverse events (AEs) will be measured by the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PED-PRO-CTCAE). This study will measure the incidence of 15 core AEs (abdominal pain, anorexia, nausea, vomiting, constipation, diarrhea, cough, pain, headache, neuropathy, mucositis, anxiety, depression, fatigue, insomnia), as perceived and reported by children 7 to 18 years of age or parent proxy (0-18 years), using a 7-day reference period with 4 response options per item. Presence of each of the 15 AEs will be measured as a dichotomous variable of the AE symptom (1-if any of the AEs happens; 0-none AEs). It is a repeated measurement, will be measured at baseline and every four weeks, for seven times.
Measured: Measured every four weeks over six months.
Scores of children's mobility
Scores of children's mobility will be measured by Pediatric patient-reported outcomes measurement information system (Pediatric PROMIS) Short Form v2.0 - Mobility 8a. It can be reported by children 7 to 18 years of age or parent proxy (0-18 years) in relation to the past 7 days and in terms of a five-point response option range from 'never' to 'almost always' in most measures. Higher scores mean more of the measured symptom being experienced. The short form measure has 8 items and receives a T-score with a mean of 50 and a standard deviation of 10 based on the original reference sample. It is a repeated measurement, will be measured at baseline and every four weeks, for seven times.
Measured: Measured every three months over six months.
Scores of children's family caregivers' care burden
Scores of children's family caregivers' care burden will be measured by Zarit Burden Inventory, by the family caregivers' self-reports. It is a 22-item, 5-point scale ranging from never (0) to always (4). A higher score indicates higher care burden. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
Measured: Measured every three months over six months.
Scores of children's family caregivers' anxiety
Scores of children's family caregivers' anxiety will be measured by Zung's Self-Rating Anxiety Scale (SAS), by the family caregivers' self-reports. It is a 20-item, 4-point scale ranging from never (1) to often (4). The total score of 1.25 is the final standard score. A higher score indicates a severer anxiety symptom. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
Measured: Measured every three months over six months.
Scores of children's family caregivers' depression
Scores of children's family caregivers' depression will be measured by Zung's Self-Rating Depression Scale (SDS) , by the family caregivers' self-reports. It is a 20-item, 4-point scale ranging from never (1) to often (4). The total score of 1.25 is the final standard score. A higher score indicates severer depressive symptoms. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
Measured: Measured every three months over six months.
Acceptability of the NiCE intervention
Acceptability will be captured by interviews of family caregivers and healthcare workers about whether the content of this intervention is acceptable. Each participant will be asked about the same question: "Please tell me whether you think this intervention is acceptable? Please tell me more about your answer to this question". Acceptability will be defined when the participant clearly answered "yes".
Measured: At the sixth month of the study.
Appropriateness of the NiCE intervention
Appropriateness will be assessed by interviews of family caregivers and healthcare workers of the intervention arm whether the content of this intervention is appropriate. Each participant will be asked about the same question: "Please tell me whether you think this intervention is appropriate? Please tell me more about your answer to this question". Appropriateness will be defined when the participant clearly answered "yes".
Measured: At the sixth month of the study.
Feasibility of the NiCE intervention
Feasibility will be assessed by the number of nurses led conversations that actually occurred during the 6-month period.
Measured: At the sixth month of the study.
Barriers and facilitators
Barriers and facilitators will be assessed by interviews of family caregivers and healthcare workers of the intervention arm. Each participant will be asked about the same two questions: (1) "Please tell me whether you think there is any barrier during the intervention? Please tell me more about your answer to this question". (2) "Please tell me whether you think there is any facilitators during the intervention? Please tell me more about your answer to this question".
Measured: At the sixth month of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Aug 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowen Zhai, MD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306509
- Sponsor's protocol ID
- NiCE_21_427
- Acronym
- NiCE
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt P, Otto M, Hechler T, Metzing S, Wolfe J, Zernikow B. Did increased availability of pediatric palliative care lead to improved palliative care outcomes in children with cancer? J Palliat Med. 2013 Sep;16(9):1034-9. doi: 10.1089/jpm.2013.0014. Epub 2013 Jul 31.
PubMed 23901834Snaman J, McCarthy S, Wiener L, Wolfe J. Pediatric Palliative Care in Oncology. J Clin Oncol. 2020 Mar 20;38(9):954-962. doi: 10.1200/JCO.18.02331. Epub 2020 Feb 5.
PubMed 32023163Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2.
PubMed 28603881Mahmood LA, Casey D, Dolan JG, Dozier AM, Korones DN. Feasibility of Early Palliative Care Consultation for Children With High-Risk Malignancies. Pediatr Blood Cancer. 2016 Aug;63(8):1419-22. doi: 10.1002/pbc.26024. Epub 2016 May 3.
PubMed 27148856Neuburg L. Early Initiation of Pediatric Palliative Care. J Pediatr Health Care. 2021 Jan-Feb;35(1):114-119. doi: 10.1016/j.pedhc.2020.05.006. Epub 2020 Jul 10.
PubMed 32660809Lafond DA, Kelly KP, Hinds PS, Sill A, Michael M. Establishing Feasibility of Early Palliative Care Consultation in Pediatric Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2015 Sep-Oct;32(5):265-77. doi: 10.1177/1043454214563411. Epub 2015 Jan 23.
PubMed 25616372Levine DR, Johnson LM, Snyder A, Wiser RK, Gibson D, Kane JR, Baker JN. Integrating Palliative Care in Pediatric Oncology: Evidence for an Evolving Paradigm for Comprehensive Cancer Care. J Natl Compr Canc Netw. 2016 Jun;14(6):741-8. doi: 10.6004/jnccn.2016.0076.
PubMed 27283167Baker JN, Hinds PS, Spunt SL, Barfield RC, Allen C, Powell BC, Anderson LH, Kane JR. Integration of palliative care practices into the ongoing care of children with cancer: individualized care planning and coordination. Pediatr Clin North Am. 2008 Feb;55(1):223-50, xii. doi: 10.1016/j.pcl.2007.10.011.
PubMed 18242323
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Early Integration of Palliative Care in Pediatric Oncology: Development and Implementation of a Nurse-initiated Conversation Program for Pediatric Cancer Patients and Their Families
- ClinicalTrials.gov ID
- NCT05306509
- Acronym / sponsor ID
- NiCE / NiCE_21_427
- Conditions
- Solid Tumor, Hematological Malignancies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.
Detailed description
Early integration of PPC, endorsed by a number of international societies, is well supported by evidence on providing multi-layer relief in children and their families over the course of any life-threatening illness. This study will leverage oncology nurses' role, culturally adapt the well-recognized St. Jude Children's Individualized Care Planning and Coordination (ICPC) Model to develop and evaluate a nurse-initiated conversation program to facilitate early integration of palliative care in pediatric oncology care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-initiated conversations for early integration of palliative care (NiCE) | Experimental | Behavioral: NiCEParticipants will receive nurse-initiated conversations facilitating early integration of palliative care in pediatric oncology. |
| Routine PPC | Other | Other: Routine PPCParticipants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children within eight weeks of initial oncologic diagnosis or within eight weeks of relapse/recurrent disease diagnosis
- Children speaking Chinese
- Children's family caregivers accompanying the child in the hospital (only one family member is eligible to take this role under current hospital policy)
- Children's family caregivers speaking Chinese
- Health care providers who are taking care of the eligible children, including but not limited to physicians, nurses, and social workers
Key exclusion criteria (1 listed)
- Children who, in the opinion of their physician, are not capable mentally or verbally of participating in the survey or interview
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 |
|---|---|---|
| NiCEParticipants will receive an initial conversation led by a trained senior nurse within eight weeks after initial oncologic diagnosis or relapse/recurrent disease diagnosis, with an introduction to the intervention and learning about the goals, values, hopes, and fears of each patient and family. The PPC team will then follow each patient by ongoing regular conversations (related to the child and family's conditions) led by the same nurse, every 4 weeks for six months, when symptom assessment and management, goal-directed supportive care, team collaboration, and care coordination will be delivered according to the family's needs. Increased PPC involvement, end-of-life care and bereavement care will be involved when necessary. If a participant feels any discomfort or distress during the intervention, a break will be taken until they feel better. If not, the central contact person will come and discussion about the participant's feeling and wiliness to continue the intervention. | Behavioural | Nurse-initiated conversations for early integration of palliative care (NiCE) |
| Routine PPCParticipants will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment. | Other | Routine PPC |
Primary outcome
Scores of children's quality of life
Time frame: Measured every three months over six months.
Scores of children's quality of life will be measured by Peds Quality of Life TM4.0 scale. It encompasses four subscales: physical, emotional, social and school functioning. It asks how much of a problem each item has been during the past month. It comprised of parallel child self-report and parent proxy-report formats. Child self-report includes ages 5-7 years (young child), ages 8-12 years (child), and ages 13-18 years (adolescent). All items use a five-point Likert response set range from 'never' to 'almost always'. Items are reverse-scored and linear-early transformed to a scale of 0 to 100 (0 = 100, 1= 75, 2= 50, 3= 25, 4=0), so that higher scores indicate a better quality of life. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
9 secondary outcomes
Incidence of adverse events
Time frame: Measured every four weeks over six months.
Scores of children's mobility
Time frame: Measured every three months over six months.
Scores of children's family caregivers' care burden
Time frame: Measured every three months over six months.
Scores of children's family caregivers' anxiety
Time frame: Measured every three months over six months.
Scores of children's family caregivers' depression
Time frame: Measured every three months over six months.
Acceptability of the NiCE intervention
Time frame: At the sixth month of the study.
Appropriateness of the NiCE intervention
Time frame: At the sixth month of the study.
Feasibility of the NiCE intervention
Time frame: At the sixth month of the study.
Barriers and facilitators
Time frame: At the sixth month of the study.
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 19 Mar 2026.
- Background: PubMed 23901834Schmidt P, Otto M, Hechler T, Metzing S, Wolfe J, Zernikow B. Did increased availability of pediatric palliative care lead to improved palliative care outcomes in children with cancer? J Palliat Med. 2013 Sep;16(9):1034-9. doi: 10.1089/jpm.2013.0014. Epub 2013 Jul 31.
- Background: PubMed 32023163Snaman J, McCarthy S, Wiener L, Wolfe J. Pediatric Palliative Care in Oncology. J Clin Oncol. 2020 Mar 20;38(9):954-962. doi: 10.1200/JCO.18.02331. Epub 2020 Feb 5.
- Background: PubMed 28603881Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2.
- Background: PubMed 27148856Mahmood LA, Casey D, Dolan JG, Dozier AM, Korones DN. Feasibility of Early Palliative Care Consultation for Children With High-Risk Malignancies. Pediatr Blood Cancer. 2016 Aug;63(8):1419-22. doi: 10.1002/pbc.26024. Epub 2016 May 3.
- Background: PubMed 32660809Neuburg L. Early Initiation of Pediatric Palliative Care. J Pediatr Health Care. 2021 Jan-Feb;35(1):114-119. doi: 10.1016/j.pedhc.2020.05.006. Epub 2020 Jul 10.
- Background: PubMed 25616372Lafond DA, Kelly KP, Hinds PS, Sill A, Michael M. Establishing Feasibility of Early Palliative Care Consultation in Pediatric Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2015 Sep-Oct;32(5):265-77. doi: 10.1177/1043454214563411. Epub 2015 Jan 23.
- Background: PubMed 27283167Levine DR, Johnson LM, Snyder A, Wiser RK, Gibson D, Kane JR, Baker JN. Integrating Palliative Care in Pediatric Oncology: Evidence for an Evolving Paradigm for Comprehensive Cancer Care. J Natl Compr Canc Netw. 2016 Jun;14(6):741-8. doi: 10.6004/jnccn.2016.0076.
- Background: PubMed 18242323Baker JN, Hinds PS, Spunt SL, Barfield RC, Allen C, Powell BC, Anderson LH, Kane JR. Integration of palliative care practices into the ongoing care of children with cancer: individualized care planning and coordination. Pediatr Clin North Am. 2008 Feb;55(1):223-50, xii. doi: 10.1016/j.pcl.2007.10.011.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Xiaowen Zhai, MD principal investigator
Children's Hospital of Fudan 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 NiCE and Routine PPC in people with Solid Tumor and Hematological Malignancies, run by Children's Hospital of Fudan University at 1 site in China.
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 1 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 19 Mar 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 China. 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 Lei Cheng, PhD (+8602164161784, chenglei@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of children's quality of life (time frame: Measured every three months over six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306509, which also lists 8 linked publications.
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 19 Mar 2026.