Chemotherapy-induced Peripheral NeuropathyPhase 2CINCAN-2NCT04582591
Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy
A Phase 2 study testing Cannabidiol 100 MG/ML in people with Chemotherapy-induced Peripheral Neuropathy, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Cannabidiol 100 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2021to 30 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- A diagnosis of cancer.
- Fulfill criteria for starting chemotherapy.
- Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
- If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).
Who cannot join
- Unable to complete PRO-measurements.
- Previously received taxanes or platinum-based chemotherapy.
- If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.
- Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion.
- Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
- Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.
Show all 9Show fewer
- Women who are breastfeeding.
- Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
- CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Oncology and Palliative Care
Roskilde, 4000
About this study
Official title: A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.
Read the detailed description
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
- Being tested
- Cannabidiol 100 MG/ML
- Keywords
- CIPN, Cannabinoid, Cannabidiol, CBD, Neurotoxic Chemotherapy, paclitaxel, oxaliplatin, Peripheral Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol 100 MG/MLDrug
Also called CBD
Patients receive cannabidiol before and after treatment with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment Receives: Drug: Cannabidiol 100 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
Difference in the North Central Cancer Treatment Group (NCCTG)- acute-CIPN Questionnaire from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
The Questionnaire contains single items questions, answerable on a 0-10 numeric scale, 0 corresponds to no symptoms and 10 worst possible symptoms.
Measured: up to 5 days
Difference in Vibrograms from baseline and during 1. course chemotherapy.
Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
Measured: up to 5 days
Secondary outcomes (17)
Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).
For patients receiving paclitaxel-based chemotherapy
Measured: through study completion, an average of 1 year and 6 months
Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4)
For patients receiving oxaliplatin-based chemotherapy
Measured: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 3
For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 3.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 6
For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 6.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (PAC)
For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to 1. Follow-up, 3 mo. after chemotherapy.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 9 months
Difference in CIPN from baseline to after chemotherapy course no. 2
For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 2.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 4
For patients receiving oxaliplatin: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 4.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (OX)
For patients receiving oxaliplatin: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to 1. Follow-up, 3 mo. after chemotherapy.
The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72.
Measured: through study completion, an average of 1 year and 9 months
Difference in QoL from baseline to after chemotherapy course no. 3
For patients receiving paclitaxel: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 3.
The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales.
Measured: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 6.
For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 6.
The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales.
Measured: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 2
For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 2.
The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales.
Measured: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 4
For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 4.
The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales.
Measured: through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 1
For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 6.
Measured: through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 2
For patients receiving oxaliplatin: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 4.
Measured: through study completion, an average of 1 year and 6 months
Dose reductions
Number of patients needing a dose reduction in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Measured: through study completion, an average of 1 year and 6 months
Dose delays
Number of patients needing a dose delay in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Measured: through study completion, an average of 1 year and 6 months
Not completing planned courses of chemotherapy
Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered).
Measured: through study completion, an average of 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start3 Mar 2021
- Primary completion5 Jan 2022
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jørn Herrstedt, DMSc, Study chair, Zealand University Hospital / University of CopenhagenSebastian W Nielsen, MD, Principal investigator, Zealand University Hospital / University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582591
- Sponsor's protocol ID
- REG-114-2020
- Acronym
- CINCAN-2
- Status last verified
- Jul 2021
- First submitted
- 29 Sep 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
- ClinicalTrials.gov ID
- NCT04582591
- Acronym / sponsor ID
- CINCAN-2 / REG-114-2020
- Keywords
- CIPN, Cannabinoid, Cannabidiol, CBD, Neurotoxic Chemotherapy, paclitaxel, oxaliplatin, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 9 Oct 2020 (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 protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.
Detailed description
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Cannabidiol 100 MG/MLPatients will receive cannabidiol in conjunction with their standard chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age.
- A diagnosis of cancer.
- Fulfill criteria for starting chemotherapy.
- Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
- If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).
Key exclusion criteria (9 listed)
- Unable to complete PRO-measurements.
- Previously received taxanes or platinum-based chemotherapy.
- If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.
- Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion.
- Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
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 |
|---|---|---|
| Cannabidiol 100 MG/MLAlso: CBDPatients receive cannabidiol before and after treatment with chemotherapy | Drug | Cannabidiol |
Primary outcome
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
Time frame: up to 5 days
Difference in the North Central Cancer Treatment Group (NCCTG)- acute-CIPN Questionnaire from baseline compared to 3-5 days after initiation of chemotherapy course no. 1. The Questionnaire contains single items questions, answerable on a 0-10 numeric scale, 0 corresponds to no symptoms and 10 worst possible symptoms.
Difference in Vibrograms from baseline and during 1. course chemotherapy.
Time frame: up to 5 days
Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
17 secondary outcomes
Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).
Time frame: through study completion, an average of 1 year and 6 months
Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4)
Time frame: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 3
Time frame: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 6
Time frame: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (PAC)
Time frame: through study completion, an average of 1 year and 9 months
Difference in CIPN from baseline to after chemotherapy course no. 2
Time frame: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 4
Time frame: through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (OX)
Time frame: through study completion, an average of 1 year and 9 months
Difference in QoL from baseline to after chemotherapy course no. 3
Time frame: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 6.
Time frame: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 2
Time frame: through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 4
Time frame: through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 1
Time frame: through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 2
Time frame: through study completion, an average of 1 year and 6 months
Dose reductions
Time frame: through study completion, an average of 1 year and 6 months
Dose delays
Time frame: through study completion, an average of 1 year and 6 months
Not completing planned courses of chemotherapy
Time frame: through study completion, an average of 1 year and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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.
Jørn Herrstedt, DMSc study chair
Zealand University Hospital / University of Copenhagen
Sebastian W Nielsen, MD principal investigator
Zealand University Hospital / University of Copenhagen
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 Cannabidiol 100 MG/ML in people with Chemotherapy-induced Peripheral Neuropathy, run by Zealand University Hospital at 1 site in Denmark.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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 Denmark. 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?
Results are not available in the source record.
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?
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy. (time frame: up to 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.