Bladder CarcinomaENHANCENCT05480735
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy
A study testing Prehabilitation in people with Bladder Carcinoma, run by The Netherlands Cancer Institute at 8 sites in Netherlands.
Trial summary
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 8 sitesNetherlands
- Study dates
- 11 Aug 2022to Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
- Planned to undergo radical cystectomy,
- Age ≥ 18 years.
Who cannot join
- Subjects with severe cognitive or psychiatric disorders,
- Subjects who are operated within 3 weeks,
- Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires,
- Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET),
- Subject who are unable or unwilling to participate in the intervention.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, Wilhelminalaan 12, 1815 JD
Siebe Bos
- Recruiting
Rijnstate
Arnhem, Wagnerlaan 55, 6815 AD
Carl Wijburg
- Recruiting
Catharina Ziekenhuis
Eindhoven, Michelangelolaan 2, 5623 EJ
Evert Koldewijn
- Recruiting
UMC Groningen
Groningen, Hanzeplein 1, 9713 GZ
Annemarie Leliveld
- Recruiting
Maastricht UMC+
Maastricht, P. Debyelaan 25, 6229 HX
Bart Bongers
- Recruiting
Radboudumc
Nijmegen, Geert Grooteplein Zuid 10, 6525 GA
Toine van der Heijden
- Recruiting
Erasmus Medical Center
Rotterdam, Doctor Molewaterplein 40, 3015 GD
Joost Boormans
- Recruiting
UMC Utrecht
Utrecht, Heidelberglaan 100, 3584 CX
Anne M. May, Prof. dr., a.m.may@umcutrecht.nl
About this study
Official title: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.
Read the detailed description
The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.
- Conditions
- Bladder Carcinoma
- Being tested
- Prehabilitation
- Keywords
- prehabilitation, bladder cancer, exercise, smoking cessation, nutritional support, surgical complications, cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Motor Activity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Multimodal prehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke.
Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. Receives: Behavioral: Prehabilitation |
| Control group | No intervention | Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records
Measured: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)
Secondary outcomes (27)
High grade complications
Clavien Dindo grade 3 or higher
Measured: 0-12 weeks post-surgery
Duration of hospital stay
Time from admission until hospital discharge
Measured: 0-12 weeks post-surgery
Readmissions
Hospital readmission as recorded in medical file
Measured: 0-12 weeks post-surgery
Disease status
Progression/recurrence, any additional treatment as recorded in medical file
Measured: 0-12 weeks post-surgery
Change in cardiorespiratory fitness
Assessed via cardiopulmonary exercise test (CPET)
Measured: T0a (baseline), T1 (within 1 week before surgery)
Change in muscle strength
Grip strength
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in muscle strength
30s chair stands
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in physical performance
Short Physical Performance Battery (SPPB)
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in nutritional status
Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in body composition
Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Nil per mouth consumption during hospitalization
The total days as recorded in medical file
Measured: 0-12 weeks post-surgery
Change in weight
Measured in KG
Measured: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Height
Measured in cm
Measured: T0a (baseline) - T3 (12 weeks post-surgery)
Change in smoking status
Self-developed questionnaire
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Sense of coherence (SOC)
13-item SOC questionnaire
Measured: T0a (baseline)
Change in fatigue
MFI questionnaire
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in HRQoL
EORTC QLQ-C30
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in muscle invasive bladder cancer specific scores
EORTC QLQ-BLM30
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in health status
EQ-5D-5L
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in physical activity
SQUASH questionnaire
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in anxiety and depression
HADS questionnaire
Measured: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Intervention costs
Cost analysis
Measured: T0a (baseline) - T3 (12 weeks post-surgery)
Healthcare resources consumption
Medical Consumption Questionnaire (iMCQ)
Measured: T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy)
Work status
Productivity Cost Questionnaire (iPCQ)
Measured: T0a (baseline) - T3 (12 weeks post-surgery)
Satisfaction with prehabilitation in intervention group and evaluation in control group
Self-developed questionnaire
Measured: T3 (12 weeks post-surgery)
Non participation analysis
Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via questionnaire
Measured: T0a (baseline)
Hypoxia
To study the effectiveness of the prehabilitation program in terms of inducing favorable changes in tumor hypoxia markers
Measured: T3 (12 weeks post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start11 Aug 2022
- Primary completionDec 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, University Medical Center Groningen, Radboud University Medical Center, Rijnstate Hospital, Noordwest Ziekenhuisgroep, Erasmus Medical Center, Maastricht University Medical Center, Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480735
- Sponsor's protocol ID
- NL78792.031.22
- Acronym
- ENHANCE
- Status last verified
- Oct 2022
- First submitted
- 14 Jul 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patients are asked informed consent for data sharing with POLARIS consortium
Publications
Akdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.
PubMed 36882246
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05480735
- Acronym / sponsor ID
- ENHANCE / NL78792.031.22
- Conditions
- Bladder Carcinoma
- Keywords
- prehabilitation, bladder cancer, exercise, smoking cessation, nutritional support, surgical complications, cystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- UMC Utrecht, University Medical Center Groningen, Radboud University Medical Center, Rijnstate Hospital, Noordwest Ziekenhuisgroep, Erasmus Medical Center, Maastricht University Medical Center, Karolinska Institutet
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.
Detailed description
The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: PrehabilitationThe intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. |
| Control group | No intervention | –Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
- Planned to undergo radical cystectomy,
- Age ≥ 18 years.
Key exclusion criteria (5 listed)
- Subjects with severe cognitive or psychiatric disorders,
- Subjects who are operated within 3 weeks,
- Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires,
- Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET),
- Subject who are unable or unwilling to participate in the intervention.
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 |
|---|---|---|
| PrehabilitationMultimodal prehabilitation program | Behavioural | Prehabilitation group |
Primary outcome
Complications
Time frame: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)
The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records
27 secondary outcomes
High grade complications
Time frame: 0-12 weeks post-surgery
Duration of hospital stay
Time frame: 0-12 weeks post-surgery
Readmissions
Time frame: 0-12 weeks post-surgery
Disease status
Time frame: 0-12 weeks post-surgery
Change in cardiorespiratory fitness
Time frame: T0a (baseline), T1 (within 1 week before surgery)
Change in muscle strength
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in muscle strength
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in physical performance
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in nutritional status
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Change in body composition
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Nil per mouth consumption during hospitalization
Time frame: 0-12 weeks post-surgery
Change in weight
Time frame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Height
Time frame: T0a (baseline) - T3 (12 weeks post-surgery)
Change in smoking status
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Sense of coherence (SOC)
Time frame: T0a (baseline)
Change in fatigue
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in HRQoL
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in muscle invasive bladder cancer specific scores
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in health status
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in physical activity
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Change in anxiety and depression
Time frame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Intervention costs
Time frame: T0a (baseline) - T3 (12 weeks post-surgery)
Healthcare resources consumption
Time frame: T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy)
Work status
Time frame: T0a (baseline) - T3 (12 weeks post-surgery)
Satisfaction with prehabilitation in intervention group and evaluation in control group
Time frame: T3 (12 weeks post-surgery)
Non participation analysis
Time frame: T0a (baseline)
Hypoxia
Time frame: T3 (12 weeks post-surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 36882246Akdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.
- Individual participant dataSharing planned: Undecided. Patients are asked informed consent for data sharing with POLARIS consortium
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Bladder Carcinoma, run by The Netherlands Cancer Institute at 8 sites in Netherlands.
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 3 inclusion and 5 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martijn Stuiver, PhD (+31205124136, m.stuiver@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)). 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 NCT05480735, which also lists 1 linked publication.
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 31 Oct 2022.