RehabilitationNCT05958433
Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
A study testing Rehabilitation with stoma appliance in people with Rehabilitation, run by Assiut University.
Trial summary
This is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Rehabilitation with stoma appliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective operable colorectal resections that would require the formation of a temporary or permanent stoma.
- Patients who were likely to be self-sufficient in managing their stoma pouching system after surgery.
Who cannot join
- Those who undergo emergency surgery
- Disoriented patients who cannot cooperate.
- Patients with psychiatric disease.
Trial locations and contacts
No sites are listed yet.
Doaa Wadie, Proffesor contact
About this study
Official title: Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients, A Randomized Controlled Trial
This is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma.
Read the detailed description
Colorectal cancer is third cancer worldwide after breast and lung cancer accounting for 10% of all cancer cases and 9.4% of cancer deaths. Over 2.2 million new colorectal cancer cases and 1.8 million deaths have been estimated to occur in 2020. In Egypt, it is the seventh cancer, accounting for 3.9% of all cancers, with about 5,000 new cases annually.
Colorectal resections are often associated with temporary or permanent stoma formations. In the United Kingdom it is estimated that more than 20,000 new stomas are created each year, 11,800 of them were colostomies. About one-half of the stoma was permanent. The formation of a stoma is associated with psychologic morbidity, which can be reduced with preoperative and postoperative patient education and psychologic support.
Living with a stoma is a challenging situation for various reasons including uncontrolled gas passage through it, diarrhea, odor, and leakage around the stoma or appliance. It would take several months for the patients to adjust to this difficult time. At that point, the patient's Quality of life becomes essential for the remaining time.
Ostomy formation is one of the therapeutic procedures performed to manage bowel dysfunction due to various reasons; however, it affects quality of life of patients. World health organization defines QOL as an individual's perspective of his/her health status concerning a few aspects- physical, psychological, economic, social, and environmental.
A stoma influences the physical, mental, emotional, and social life of the patient significantly. A good quality of life is essential to achieve a comprehensive approach to treating patients. A study done in China to assess stoma related quality of life using a stoma self-care agency scale and health hope index showed that patients had difficulties in work and social institutions. Additional concerns pointed out were sexuality, body image and the stoma itself. A long-term effect on the quality of life of members of the United Ostomy Association of America after 5 years of ostomy surgery was assessed using a questionnaire. Their report has shown that patients feel better as they live longer with the stoma. Research done on Iranian by ostomy society has shown that factors such as the type of ostomy, the underlying disease that had led to the stoma formation, depression after ostomy, dissatisfaction with sexual activities, a problem with the location of ostomy and change in clothing style affected the Quality of Life.
Ostomies can lead to intensified distress and suffering in patients because of skin irritation (76%), pouch leakage (62%), offensive odor (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). In such circumstances, it is worthwhile to assess the quality of life in the evaluation of the outcomes of various therapeutic procedures along with their final impact on patients' lives. Quality of care and training provided to patients can be associated with their subsequent quality of life. The main aim of this study is to assess the effects of preoperative education on stoma self-care, quality of life, Anxiety, and depression levels in colorectal cancer patients with a stoma.
- Conditions
- Rehabilitation
- Being tested
- Rehabilitation with stoma appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with stoma applianceBehavioural
The rehabilitation group will receive preoperative stoma education in addition, a water-filled ostomy appliance (50-100 ml) will be attached 48 hours before surgery. These pouches will not be removed until surgery, and the EST nurse will teach the patients preoperatively how to manage the ostomy appliance with similar standards as described in the usual postoperative stoma care.
| Study group | Role | What they receive |
|---|---|---|
| standard postoperative education. | Active comparator | These patients will receive stoma care and stoma education beginning on postoperative day1. Receives: Behavioral: Rehabilitation with stoma appliance |
| preoperative rehabilitation group | Experimental | The rehabilitation group will receive preoperative stoma education in addition Receives: Behavioral: Rehabilitation with stoma appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of hospital stay
Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.
Measured: 1 year
Secondary outcomes (2)
Assess anxiety and depression
Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale).
0-7 normal 8-10 border line abnormal 11-21 abnormal
Measured: 9 monthes
assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire.
recall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
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 RehabilitationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana kamal, Assiut University
- Investigators
- Nelly AliEldien, proffesor, Study chair, Prof. Biostatistics & Cancer Epidemiology National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958433
- Sponsor's protocol ID
- PRWSACRC
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Archambault AN, Su YR, Jeon J, Thomas M, Lin Y, Conti DV, Win AK, Sakoda LC, Lansdorp-Vogelaar I, Peterse EFP, Zauber AG, Duggan D, Holowatyj AN, Huyghe JR, Brenner H, Cotterchio M, Bezieau S, Schmit SL, Edlund CK, Southey MC, MacInnis RJ, Campbell PT, Chang-Claude J, Slattery ML, Chan AT, Joshi AD, Song M, Cao Y, Woods MO, White E, Weinstein SJ, Ulrich CM, Hoffmeister M, Bien SA, Harrison TA, Hampe J, Li CI, Schafmayer C, Offit K, Pharoah PD, Moreno V, Lindblom A, Wolk A, Wu AH, Li L, Gunter MJ, Gsur A, Keku TO, Pearlman R, Bishop DT, Castellvi-Bel S, Moreira L, Vodicka P, Kampman E, Giles GG, Albanes D, Baron JA, Berndt SI, Brezina S, Buch S, Buchanan DD, Trichopoulou A, Severi G, Chirlaque MD, Sanchez MJ, Palli D, Kuhn T, Murphy N, Cross AJ, Burnett-Hartman AN, Chanock SJ, de la Chapelle A, Easton DF, Elliott F, English DR, Feskens EJM, FitzGerald LM, Goodman PJ, Hopper JL, Hudson TJ, Hunter DJ, Jacobs EJ, Joshu CE, Kury S, Markowitz SD, Milne RL, Platz EA, Rennert G, Rennert HS, Schumacher FR, Sandler RS, Seminara D, Tangen CM, Thibodeau SN, Toland AE, van Duijnhoven FJB, Visvanathan K, Vodickova L, Potter JD, Mannisto S, Weigl K, Figueiredo J, Martin V, Larsson SC, Parfrey PS, Huang WY, Lenz HJ, Castelao JE, Gago-Dominguez M, Munoz-Garzon V, Mancao C, Haiman CA, Wilkens LR, Siegel E, Barry E, Younghusband B, Van Guelpen B, Harlid S, Zeleniuch-Jacquotte A, Liang PS, Du M, Casey G, Lindor NM, Le Marchand L, Gallinger SJ, Jenkins MA, Newcomb PA, Gruber SB, Schoen RE, Hampel H, Corley DA, Hsu L, Peters U, Hayes RB. Cumulative Burden of Colorectal Cancer-Associated Genetic Variants Is More Strongly Associated With Early-Onset vs Late-Onset Cancer. Gastroenterology. 2020 Apr;158(5):1274-1286.e12. doi: 10.1053/j.gastro.2019.12.012. Epub 2019 Dec 19.
PubMed 31866242Chaudhri S, Brown L, Hassan I, Horgan AF. Preoperative intensive, community-based vs. traditional stoma education: a randomized, controlled trial. Dis Colon Rectum. 2005 Mar;48(3):504-9. doi: 10.1007/s10350-004-0897-0.
PubMed 15768181Zewude WC, Derese T, Suga Y, Teklewold B. Quality of Life in Patients Living with Stoma. Ethiop J Health Sci. 2021 Sep;31(5):993-1000. doi: 10.4314/ejhs.v31i5.11.
PubMed 35221616Anaraki F, Vafaie M, Behboo R, Maghsoodi N, Esmaeilpour S, Safaee A. Quality of life outcomes in patients living with stoma. Indian J Palliat Care. 2012 Sep;18(3):176-80. doi: 10.4103/0973-1075.105687.
PubMed 23439841Richbourg L, Thorpe JM, Rapp CG. Difficulties experienced by the ostomate after hospital discharge. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):70-9. doi: 10.1097/00152192-200701000-00011.
PubMed 17228210Krouse RS, Grant M, Rawl SM, Mohler MJ, Baldwin CM, Coons SJ, McCorkle R, Schmidt CM, Ko CY. Coping and acceptance: the greatest challenge for veterans with intestinal stomas. J Psychosom Res. 2009 Mar;66(3):227-33. doi: 10.1016/j.jpsychores.2008.09.009. Epub 2009 Jan 16.
PubMed 19232235Prieto L, Thorsen H, Juul K. Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. Health Qual Life Outcomes. 2005 Oct 12;3:62. doi: 10.1186/1477-7525-3-62.
PubMed 16219109Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
PubMed 25511175
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05958433
- Acronym / sponsor ID
- PRWSACRC
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 24 Jul 2023 (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 is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma.
Detailed description
Colorectal cancer is third cancer worldwide after breast and lung cancer accounting for 10% of all cancer cases and 9.4% of cancer deaths. Over 2.2 million new colorectal cancer cases and 1.8 million deaths have been estimated to occur in 2020. In Egypt, it is the seventh cancer, accounting for 3.9% of all cancers, with about 5,000 new cases annually.
Colorectal resections are often associated with temporary or permanent stoma formations. In the United Kingdom it is estimated that more than 20,000 new stomas are created each year, 11,800 of them were colostomies. About one-half of the stoma was permanent. The formation of a stoma is associated with psychologic morbidity, which can be reduced with preoperative and postoperative patient education and psychologic support.
Living with a stoma is a challenging situation for various reasons including uncontrolled gas passage through it, diarrhea, odor, and leakage around the stoma or appliance. It would take several months for the patients to adjust to this difficult time. At that point, the patient's Quality of life becomes essential for the remaining time.
Ostomy formation is one of the therapeutic procedures performed to manage bowel dysfunction due to various reasons; however, it affects quality of life of patients. World health organization defines QOL as an individual's perspective of his/her health status concerning a few aspects- physical, psychological, economic, social, and environmental.
A stoma influences the physical, mental, emotional, and social life of the patient significantly. A good quality of life is essential to achieve a comprehensive approach to treating patients. A study done in China to assess stoma related quality of life using a stoma self-care agency scale and health hope index showed that patients had difficulties in work and social institutions. Additional concerns pointed out were sexuality, body image and the stoma itself. A long-term effect on the quality of life of members of the United Ostomy Association of America after 5 years of ostomy surgery was assessed using a questionnaire. Their report has shown that patients feel better as they live longer with the stoma. Research done on Iranian by ostomy society has shown that factors such as the type of ostomy, the underlying disease that had led to the stoma formation, depression after ostomy, dissatisfaction with sexual activities, a problem with the location of ostomy and change in clothing style affected the Quality of Life.
Ostomies can lead to intensified distress and suffering in patients because of skin irritation (76%), pouch leakage (62%), offensive odor (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). In such circumstances, it is worthwhile to assess the quality of life in the evaluation of the outcomes of various therapeutic procedures along with their final impact on patients' lives. Quality of care and training provided to patients can be associated with their subsequent quality of life. The main aim of this study is to assess the effects of preoperative education on stoma self-care, quality of life, Anxiety, and depression levels in colorectal cancer patients with a stoma.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard postoperative education. | Active comparator | Behavioral: Rehabilitation with stoma applianceThese patients will receive stoma care and stoma education beginning on postoperative day1. |
| preoperative rehabilitation group | Experimental | Behavioral: Rehabilitation with stoma applianceThe rehabilitation group will receive preoperative stoma education in addition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective operable colorectal resections that would require the formation of a temporary or permanent stoma.
- Patients who were likely to be self-sufficient in managing their stoma pouching system after surgery.
Key exclusion criteria (3 listed)
- Those who undergo emergency surgery
- Disoriented patients who cannot cooperate.
- Patients with psychiatric disease.
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 |
|---|---|---|
| Rehabilitation with stoma applianceThe rehabilitation group will receive preoperative stoma education in addition, a water-filled ostomy appliance (50-100 ml) will be attached 48 hours before surgery. These pouches will not be removed until surgery, and the EST nurse will teach the patients preoperatively how to manage the ostomy appliance with similar standards as described in the usual postoperative stoma care. | Behavioural | preoperative rehabilitation group, standard postoperative education. |
Primary outcome
duration of hospital stay
Time frame: 1 year
Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.
2 secondary outcomes
Assess anxiety and depression
Time frame: 9 monthes
assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 31866242Archambault AN, Su YR, Jeon J, Thomas M, Lin Y, Conti DV, Win AK, Sakoda LC, Lansdorp-Vogelaar I, Peterse EFP, Zauber AG, Duggan D, Holowatyj AN, Huyghe JR, Brenner H, Cotterchio M, Bezieau S, Schmit SL, Edlund CK, Southey MC, MacInnis RJ, Campbell PT, Chang-Claude J, Slattery ML, Chan AT, Joshi AD, Song M, Cao Y, Woods MO, White E, Weinstein SJ, Ulrich CM, Hoffmeister M, Bien SA, Harrison TA, Hampe J, Li CI, Schafmayer C, Offit K, Pharoah PD, Moreno V, Lindblom A, Wolk A, Wu AH, Li L, Gunter MJ, Gsur A, Keku TO, Pearlman R, Bishop DT, Castellvi-Bel S, Moreira L, Vodicka P, Kampman E, Giles GG, Albanes D, Baron JA, Berndt SI, Brezina S, Buch S, Buchanan DD, Trichopoulou A, Severi G, Chirlaque MD, Sanchez MJ, Palli D, Kuhn T, Murphy N, Cross AJ, Burnett-Hartman AN, Chanock SJ, de la Chapelle A, Easton DF, Elliott F, English DR, Feskens EJM, FitzGerald LM, Goodman PJ, Hopper JL, Hudson TJ, Hunter DJ, Jacobs EJ, Joshu CE, Kury S, Markowitz SD, Milne RL, Platz EA, Rennert G, Rennert HS, Schumacher FR, Sandler RS, Seminara D, Tangen CM, Thibodeau SN, Toland AE, van Duijnhoven FJB, Visvanathan K, Vodickova L, Potter JD, Mannisto S, Weigl K, Figueiredo J, Martin V, Larsson SC, Parfrey PS, Huang WY, Lenz HJ, Castelao JE, Gago-Dominguez M, Munoz-Garzon V, Mancao C, Haiman CA, Wilkens LR, Siegel E, Barry E, Younghusband B, Van Guelpen B, Harlid S, Zeleniuch-Jacquotte A, Liang PS, Du M, Casey G, Lindor NM, Le Marchand L, Gallinger SJ, Jenkins MA, Newcomb PA, Gruber SB, Schoen RE, Hampel H, Corley DA, Hsu L, Peters U, Hayes RB. Cumulative Burden of Colorectal Cancer-Associated Genetic Variants Is More Strongly Associated With Early-Onset vs Late-Onset Cancer. Gastroenterology. 2020 Apr;158(5):1274-1286.e12. doi: 10.1053/j.gastro.2019.12.012. Epub 2019 Dec 19.
- Background: PubMed 15768181Chaudhri S, Brown L, Hassan I, Horgan AF. Preoperative intensive, community-based vs. traditional stoma education: a randomized, controlled trial. Dis Colon Rectum. 2005 Mar;48(3):504-9. doi: 10.1007/s10350-004-0897-0.
- Background: PubMed 35221616Zewude WC, Derese T, Suga Y, Teklewold B. Quality of Life in Patients Living with Stoma. Ethiop J Health Sci. 2021 Sep;31(5):993-1000. doi: 10.4314/ejhs.v31i5.11.
- Background: PubMed 23439841Anaraki F, Vafaie M, Behboo R, Maghsoodi N, Esmaeilpour S, Safaee A. Quality of life outcomes in patients living with stoma. Indian J Palliat Care. 2012 Sep;18(3):176-80. doi: 10.4103/0973-1075.105687.
- Background: PubMed 17228210Richbourg L, Thorpe JM, Rapp CG. Difficulties experienced by the ostomate after hospital discharge. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):70-9. doi: 10.1097/00152192-200701000-00011.
- Background: PubMed 19232235Krouse RS, Grant M, Rawl SM, Mohler MJ, Baldwin CM, Coons SJ, McCorkle R, Schmidt CM, Ko CY. Coping and acceptance: the greatest challenge for veterans with intestinal stomas. J Psychosom Res. 2009 Mar;66(3):227-33. doi: 10.1016/j.jpsychores.2008.09.009. Epub 2009 Jan 16.
- Background: PubMed 16219109Prieto L, Thorsen H, Juul K. Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. Health Qual Life Outcomes. 2005 Oct 12;3:62. doi: 10.1186/1477-7525-3-62.
- Background: PubMed 25511175Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
- 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.
Doaa Wadie, Proffesor contact
Nelly AliEldien, proffesor study chair
Prof. Biostatistics & Cancer Epidemiology National Cancer Institute, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with stoma appliance in people with Rehabilitation, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora gouda, lecturer (01005627897, noraatef148@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of hospital stay (time frame: 1 year). 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 NCT05958433, 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 28 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.