Breast Cancer FemaleNCT03022162
Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer
An observational study of Breast Cancer Female and Neuropathic Pain, run by Tata Memorial Centre at 1 site in India.
Trial summary
Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Neuropathic Pain
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2017to 31 May 2018
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will consist of all female patients with primary breast cancer who received adjuvant Paclitaxel chemotherapy within the preceding 2 year period, visiting TMH from December 2017 to May 2018.
Who may be able to join
- Histopathologically confirmed Primary breast cancer
- Patients who had received adjuvant chemotherapy with Paclitaxel and who have completed their Paclitaxel chemotherapy within the preceding 2 years i.e. between 1stAugust 2014 to 31st July 2016.
Who cannot join
- Age below 18 years
- On current Paclitaxel chemotherapy
- Patients with radiological evidence of bone metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study
Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
Read the detailed description
PRIMARY AIM / OBJECTIVE:
Our study aims to observe the prevalence of CIPN-related pain in cancer breast patients who have received Paclitaxel based adjuvant chemotherapy where we define CIPN-related pain as - "possible" neuropathic pain in patients scoring more than 12 on Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS).
SECONDARY AIM / OBJECTIVE Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
MATERIALS \& METHODS:
The cohort will consist of women with early breast cancer (stages I through III) who had received Paclitaxel chemotherapy for breast cancer as per the Institutional guidelines within the preceding two years. History suggestive of pre-existing neuropathy will be noted.
- All patients (who fulfill the inclusion criteria) visiting Tata Memorial hospital during Feb2017 2016 to June 2017 will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN and CIPN-related pain score will be documented by using the NCI-CTCAE and LANSS scale. Then, the patients will be questioned for thepresence of similar neuropathic symptoms before starting, after starting and during Paclitaxel the chemotherapy and their replies will be recorded in the.
- Patients who had received adjuvant chemotherapy with Paclitaxel but who could not complete their chemotherapy due to Paclitaxel induced adverse effects other than peripheral neuropathy for eg hypersensitivity to Paclitaxel will be screened but their data will be excluded from final data assessment.
- Use of 1. Acetyl-L-carnitine (ALC) 2. Amifostine 3. Amitriptyline 4. CaMg 5. Diethyldithio-carbamate (DDTC) 6. Glutathione (GSH) 7. Nimodipine 8. All-trans-retinoic acid 9. rhuLIF 10. Vitamin E during Paclitaxel chemotherapy will be noted based on history and examination of charts.
For CIPN-related pain: The Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). If score > 12, neuropathic mechanisms are likely to be contributing to the patient's pain.
NCI-CTCAE : The National Cancer Institute - Common Terminology Criteria for Adverse Events v4.0, NCI-CTCAE most recently updated in 2010, will be used for grading CIPN. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for CIPN. Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above.
- Conditions
- Breast Cancer Female, Neuropathic Pain
- Keywords
- Neuropathic Pain, Paclitaxel, CIPN
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Paclitaxel induced CIPN-related pain
CIPN-related pain is defined as - neuropathic pain as a result of chemotherapy induced nerve damage .
All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN-related pain score will be documented by using the LANSS scale.
LANSS score>12 will be considered as possible CIPN-related pain for statistical analysis
Measured: 2 years post Paclitaxel Chemotherapy
Secondary outcomes (3)
Prevalence of Paclitaxel induced CIPN
CIPN defined as - neuropathy symptoms (other than pain) as a result of chemotherapy induced nerve damage .
All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN score will be documented by using the NCI-CTCAE v4.0 grading.
Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above for statistical analysis
Measured: 2 years post Paclitaxel Chemotherapy
temporal characteristics and risk factors of CIPN-related pain
The distribution, appearance and disappearance of syptoms related to CIPN will be based on special questionnaire.
Measured: 2 years post Paclitaxel Chemotherapy
Use of Agents offered with an intend to prevent CIPN
Use of 1. Acetyl-L-carnitine (ALC) 2. Amifostine 3. Amitriptyline 4. CaMg 5. Diethyldithio-carbamate (DDTC) 6. Glutathione (GSH) 7. Nimodipine 8. All-trans-retinoic acid 9. rhuLIF 10. Vitamin E during Paclitaxel chemotherapy will be noted based on history and examination of charts
Measured: 2 years post Paclitaxel Chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start1 Dec 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, parmanand jain, Tata Memorial Centre
- Investigators
- Anuja Bidkar, DNBAnes, Study chair, Tata Memorial CentreAparna Chatterjee, MDAnes, Study chair, Tata Memorial CentreSudeep Gupta, DMOnco, Study chair, Tata Memorial CentreParmanand Jain, MDAnes, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022162
- Sponsor's protocol ID
- 1758
- Status last verified
- Oct 2020
- First submitted
- 10 Jan 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hough SW, Kanner RM. "Cancer Pain Syndromes" in Principles & Practice of Pain Medicine edited by Warfield, Carol A.; Bajwa, Zahid H. , 2nd Edition (McGraw-Hill, 2004) p 456.
Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
PubMed 18003941Grond S, Radbruch L, Meuser T, Sabatowski R, Loick G, Lehmann KA. Assessment and treatment of neuropathic cancer pain following WHO guidelines. Pain. 1999 Jan;79(1):15-20. doi: 10.1016/S0304-3959(98)00138-9.
PubMed 9928771Wolf S, Barton D, Kottschade L, Grothey A, Loprinzi C. Chemotherapy-induced peripheral neuropathy: prevention and treatment strategies. Eur J Cancer. 2008 Jul;44(11):1507-15. doi: 10.1016/j.ejca.2008.04.018. Epub 2008 Jun 18.
PubMed 18571399Smith BH, Lee J, Price C, Baranowski AP. Neuropathic pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013 Jul;111(1):73-9. doi: 10.1093/bja/aet206.
PubMed 23794648Ventzel L, Jensen AB, Jensen AR, Jensen TS, Finnerup NB. Chemotherapy-induced pain and neuropathy: a prospective study in patients treated with adjuvant oxaliplatin or docetaxel. Pain. 2016 Mar;157(3):560-568. doi: 10.1097/j.pain.0000000000000404.
PubMed 26529271Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Jensen TS, Baron R, Haanpaa M, Kalso E, Loeser JD, Rice ASC, Treede RD. A new definition of neuropathic pain. Pain. 2011 Oct;152(10):2204-2205. doi: 10.1016/j.pain.2011.06.017. Epub 2011 Jul 18. No abstract available.
PubMed 21764514Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
PubMed 27115670
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03022162
- Acronym / sponsor ID
- 1758
- Conditions
- Breast Cancer Female, Neuropathic Pain
- Keywords
- Neuropathic Pain, Paclitaxel, CIPN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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.
Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
Detailed description
PRIMARY AIM / OBJECTIVE:
Our study aims to observe the prevalence of CIPN-related pain in cancer breast patients who have received Paclitaxel based adjuvant chemotherapy where we define CIPN-related pain as - "possible" neuropathic pain in patients scoring more than 12 on Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS).
SECONDARY AIM / OBJECTIVE Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
MATERIALS \& METHODS:
The cohort will consist of women with early breast cancer (stages I through III) who had received Paclitaxel chemotherapy for breast cancer as per the Institutional guidelines within the preceding two years. History suggestive of pre-existing neuropathy will be noted.
- All patients (who fulfill the inclusion criteria) visiting Tata Memorial hospital during Feb2017 2016 to June 2017 will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN and CIPN-related pain score will be documented by using the NCI-CTCAE and LANSS scale. Then, the patients will be questioned for thepresence of similar neuropathic symptoms before starting, after starting and during Paclitaxel the chemotherapy and their replies will be recorded in the.
- Patients who had received adjuvant chemotherapy with Paclitaxel but who could not complete their chemotherapy due to Paclitaxel induced adverse effects other than peripheral neuropathy for eg hypersensitivity to Paclitaxel will be screened but their data will be excluded from final data assessment.
- Use of 1. Acetyl-L-carnitine (ALC) 2. Amifostine 3. Amitriptyline 4. CaMg 5. Diethyldithio-carbamate (DDTC) 6. Glutathione (GSH) 7. Nimodipine 8. All-trans-retinoic acid 9. rhuLIF 10. Vitamin E during Paclitaxel chemotherapy will be noted based on history and examination of charts.
For CIPN-related pain: The Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). If score > 12, neuropathic mechanisms are likely to be contributing to the patient's pain.
NCI-CTCAE : The National Cancer Institute - Common Terminology Criteria for Adverse Events v4.0, NCI-CTCAE most recently updated in 2010, will be used for grading CIPN. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for CIPN. Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will consist of all female patients with primary breast cancer who received adjuvant Paclitaxel chemotherapy within the preceding 2 year period, visiting TMH from December 2017 to May 2018.
Key inclusion criteria (2 listed)
- Histopathologically confirmed Primary breast cancer
- Patients who had received adjuvant chemotherapy with Paclitaxel and who have completed their Paclitaxel chemotherapy within the preceding 2 years i.e. between 1stAugust 2014 to 31st July 2016.
Key exclusion criteria (3 listed)
- Age below 18 years
- On current Paclitaxel chemotherapy
- Patients with radiological evidence of bone metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Paclitaxel induced CIPN-related pain
Time frame: 2 years post Paclitaxel Chemotherapy
CIPN-related pain is defined as - neuropathic pain as a result of chemotherapy induced nerve damage . All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN-related pain score will be documented by using the LANSS scale. LANSS score>12 will be considered as possible CIPN-related pain for statistical analysis
3 secondary outcomes
Prevalence of Paclitaxel induced CIPN
Time frame: 2 years post Paclitaxel Chemotherapy
temporal characteristics and risk factors of CIPN-related pain
Time frame: 2 years post Paclitaxel Chemotherapy
Use of Agents offered with an intend to prevent CIPN
Time frame: 2 years post Paclitaxel Chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Results publicationHough SW, Kanner RM. "Cancer Pain Syndromes" in Principles & Practice of Pain Medicine edited by Warfield, Carol A.; Bajwa, Zahid H. , 2nd Edition (McGraw-Hill, 2004) p 456.
- Results publication: PubMed 18003941Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
- Results publication: PubMed 9928771Grond S, Radbruch L, Meuser T, Sabatowski R, Loick G, Lehmann KA. Assessment and treatment of neuropathic cancer pain following WHO guidelines. Pain. 1999 Jan;79(1):15-20. doi: 10.1016/S0304-3959(98)00138-9.
- Results publication: PubMed 18571399Wolf S, Barton D, Kottschade L, Grothey A, Loprinzi C. Chemotherapy-induced peripheral neuropathy: prevention and treatment strategies. Eur J Cancer. 2008 Jul;44(11):1507-15. doi: 10.1016/j.ejca.2008.04.018. Epub 2008 Jun 18.
- Results publication: PubMed 23794648Smith BH, Lee J, Price C, Baranowski AP. Neuropathic pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013 Jul;111(1):73-9. doi: 10.1093/bja/aet206.
- Results publication: PubMed 26529271Ventzel L, Jensen AB, Jensen AR, Jensen TS, Finnerup NB. Chemotherapy-induced pain and neuropathy: a prospective study in patients treated with adjuvant oxaliplatin or docetaxel. Pain. 2016 Mar;157(3):560-568. doi: 10.1097/j.pain.0000000000000404.
- Results publication: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Results publication: PubMed 21764514Jensen TS, Baron R, Haanpaa M, Kalso E, Loeser JD, Rice ASC, Treede RD. A new definition of neuropathic pain. Pain. 2011 Oct;152(10):2204-2205. doi: 10.1016/j.pain.2011.06.017. Epub 2011 Jul 18. No abstract available.
- Results publication: PubMed 27115670Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuja Bidkar, DNBAnes study chair
Tata Memorial Centre
Aparna Chatterjee, MDAnes study chair
Tata Memorial Centre
Sudeep Gupta, DMOnco study chair
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Neuropathic Pain, run by Tata Memorial Centre at 1 site in India.
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 2 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 14 Oct 2020. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Paclitaxel induced CIPN-related pain (time frame: 2 years post Paclitaxel Chemotherapy). 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 NCT03022162, which also lists 9 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 14 Oct 2020.