Gynecologic Surgical ProceduresNCT04505111
Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery
A study testing Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery in people with Gynecologic Surgical Procedures and Enhanced Recovery After Surgery, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
Trial summary
Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Surgical Procedures, Enhanced Recovery After Surgery
- What is being tested?
- Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jul 2020to 1 Oct 2020
- Phase
- Interventional
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
- Women aged between 18 and 80 years old;
- Gynecological surgery performed by laparotomy;
- Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
- Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks
Who cannot join
- Patients under 18 or older than 80 years old;
- ECOG ≥3;
- Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
- Limitation of locomotion preventing the patient to perform physical exercises;
- Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
- Emergency or urgency surgeries;
Show all 12Show fewer
- Surgeries by minimally invasive approach (laparoscopy or robotics);
- Vulvectomy or soft tissue surgery without abdominal approach;
- Minor gynaecological surgeries such as conizations;
- Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
- Non-adherence of the patient in the intervention group to the preoperative prehabilitation program.
- If surgery is performed 21 days after the last day of the prehabilitation program, for any reason
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo, São Paulo, 03102-002
About this study
Official title: Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery
Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Read the detailed description
Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery.
The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.
- Being tested
- Prehabilitation Program + Enhanced Recovery After Surgery, Enhanced Recovery After Surgery
- Keywords
- Prehabilitation, Gynecological Cancer, ERAS - Enhanced Recovery After Surgery, Gynecologic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation Program + Enhanced Recovery After SurgeryOther
Also called Prehabilitation + ERAS
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Enhanced Recovery After SurgeryOther
Also called ERAS
ERAS protocol
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation + Enhanced Recovery After Surgery | Experimental | Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team. Receives: Other: Prehabilitation Program + Enhanced Recovery After Surgery |
| Enhanced Recovery After Surgery | Active comparator | Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®. Receives: Other: Enhanced Recovery After Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recovery time
Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
Measured: Up to 30 postoperative days
Secondary outcomes (10)
Complications
Clavien-Dindo Classification, Grades I-V
Measured: Up to 30 postoperative days
Readmissions
Readmission to the Hospital Facilities
Measured: Up to 30 postoperative days
Intensive Care Unit admission rates
Postoperative Intensive Care Unit admission and stay
Measured: Up to 30 postoperative days
Health-related Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measured: At Baseline, then at 30 and 60 days postoperatively
Compliance to the ERAS® program guidelines
Compliance to ERAS® protocol and implementation of the program
Measured: Through study completion, an average of 1 year
Changes in anxiety and depression from baseline
Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
Measured: Baseline and postoperatively at 30 and 60 days
Changes in functional capacity from baseline
Patients will perform a 6-Minute Walk Test
Measured: Baseline and postoperatively at 30 and 60 days
Change in muscle strength
Muscle strength is measured by using an dynamometer
Measured: Baseline and postoperatively at 30 and 60 days
Change in body mass
Body mass is measured by using a bioelectrical impedance analysis
Measured: Baseline and postoperatively at 30 and 60 days
Hospital stay
Days from surgical procedure to hospital discharge
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start23 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Modification of the protocolo, new version was created. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Lopes, Instituto Brasileiro de Controle do Cancer
- Investigators
- Andre Lopes, MD, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505111
- Sponsor's protocol ID
- 08304219.8.0000.0072
- Status last verified
- Apr 2022
- First submitted
- 30 Jul 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the results
Publications
Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
PubMed 25076007Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
PubMed 24439570Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
PubMed 26603969Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PubMed 26757238Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PubMed 30877144Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
PubMed 14555665Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.
PubMed 25535730Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.
PubMed 31473663Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04505111
- Acronym / sponsor ID
- 08304219.8.0000.0072
- Keywords
- Prehabilitation, Gynecological Cancer, ERAS - Enhanced Recovery After Surgery, Gynecologic Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modification of the protocolo, new version was created. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 10 Aug 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.
Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Detailed description
Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery.
The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation + Enhanced Recovery After Surgery | Experimental | Other: Prehabilitation Program + Enhanced Recovery After SurgeryPatients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team. |
| Enhanced Recovery After Surgery | Active comparator | Other: Enhanced Recovery After SurgeryPatients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
- Women aged between 18 and 80 years old;
- Gynecological surgery performed by laparotomy;
- Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
- Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks
Key exclusion criteria (12 listed)
- Patients under 18 or older than 80 years old;
- ECOG ≥3;
- Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
- Limitation of locomotion preventing the patient to perform physical exercises;
- Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
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 |
|---|---|---|
| Prehabilitation Program + Enhanced Recovery After SurgeryAlso: Prehabilitation + ERASPrehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol | Other | Prehabilitation + Enhanced Recovery After Surgery |
| Enhanced Recovery After SurgeryAlso: ERASERAS protocol | Other | Enhanced Recovery After Surgery |
Primary outcome
Postoperative recovery time
Time frame: Up to 30 postoperative days
Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
10 secondary outcomes
Complications
Time frame: Up to 30 postoperative days
Readmissions
Time frame: Up to 30 postoperative days
Intensive Care Unit admission rates
Time frame: Up to 30 postoperative days
Health-related Quality of Life
Time frame: At Baseline, then at 30 and 60 days postoperatively
Compliance to the ERAS® program guidelines
Time frame: Through study completion, an average of 1 year
Changes in anxiety and depression from baseline
Time frame: Baseline and postoperatively at 30 and 60 days
Changes in functional capacity from baseline
Time frame: Baseline and postoperatively at 30 and 60 days
Change in muscle strength
Time frame: Baseline and postoperatively at 30 and 60 days
Change in body mass
Time frame: Baseline and postoperatively at 30 and 60 days
Hospital stay
Time frame: Up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 25076007Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
- Background: PubMed 24439570Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
- Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
- Background: PubMed 26603969Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
- Background: PubMed 26757238Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
- Background: PubMed 30877144Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
- Background: PubMed 14555665Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
- Background: PubMed 25535730Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.
- Background: PubMed 31473663Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: Yes. After publication of the results
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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.
Andre Lopes, MD principal investigator
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery in people with Gynecologic Surgical Procedures and Enhanced Recovery After Surgery, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
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 12 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: withdrawn, as of the sponsor's last update on 11 Apr 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Postoperative recovery time (time frame: Up to 30 postoperative days). 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 NCT04505111, which also lists 10 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 11 Apr 2022.