Gastric CancerPhase 2MyDIETNCT06385691
Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
A Phase 2 study testing myDIET software tool in people with Gastric Cancer and Oesogastric Junction Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Oesogastric Junction Cancer
- What is being tested?
- myDIET software tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2024to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patient 18 years of age or older at date of signing informed consent to participate;
- Histologically proven diagnosis of gastric adenocarcinoma or OGJ;
- Localized, resectable disease;
- Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
- Performance status (ECOG): 0-2;
- Membership of a social security scheme;
- Signed informed consent to participate.
Who cannot join
- Other associated solid cancer or haemopathy;
- Presence of severe comorbidity (Charlson index > 9)
- Presence of unbalanced dysthyroidism;
- History of gastric, duodenal or esophageal surgery;
- Inability to comply with study requirements, including :
- Impossibility for the patient or his/her caregiver to connect to myDIET;
Show all 11Show fewer
- Difficulty in understanding the written French language;
- Psychological incapacity (e.g. excessive vulnerability, psychiatric disorder) or physical incapacity (e.g. physical/motor disability);
- Patient under guardianship, curatorship or safeguard of justice;
- Patients already participating in a clinical trial or interventional study likely to interfere with the evaluation of the primary endpoint.
- Pregnant or breast-feeding patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Léon Berard
Lyon, 69008
Pamela Funk-Debleds, MD, 0469856020 ext. +33, pamela.funk-debleds@lyon.unicancer.fr
Clélia Coutzac, MD, 0469856020 ext. +33, clelia.coutzac@lyon.unicancer.fr
About this study
Official title: Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.
Read the detailed description
Gastric cancer is the 3rd leading cause of cancer mortality worldwide, with a 5-year survival rate of less than 30%. In localised gastric cancer (GC) or cancer of the oesogastric junction (OGJ), the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy (5FU, Leucovorin, Oxaliplatin, Taxotere). However, up to 51% of patients have post-operative complications, and only 60% can benefit from post-operative chemotherapy (at least one course) initiated within 12 weeks of surgery, while 46% receive the full theoretical regimen.
An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis. Undernutrition and sarcopenia increase the occurrence of post-operative complications, length of stay and post-operative readmissions. Undernutrition is an independent risk factor for failure and/or incomplete adjuvant chemotherapy, with an impact on progression-free survival and overall survival. There is a high prevalence of undernutrition in patients with GC/OGJ, estimated at 53-60%, and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively.
Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications. Early multimodal management, combining nutrition, adapted physical activity and neoadjuvant chemotherapy, is therefore recommended and essential in the perioperative situation. To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer, the CLB teams have developed a computer interface (MyDIET) linked to the myCLB patient portal. This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment, and to prevent the onset or worsening of undernutrition.
For this reason, the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CG/OGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively.
- Conditions
- Gastric Cancer, Oesogastric Junction Cancer
- Being tested
- myDIET software tool
- Keywords
- denutrition, software tool, physical activity, postoperative treatment, chemotherapy, immunotherapy
- Medical subject headings
- Stomach Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myDIET software toolOther
The tool is based on self-questionnaires completed by the patient. They are mainly filled in using visual analogue scales (from 0-10) or grades of symptoms/toxicities (Grades 0 to 4), based on the CTCAE V5. These scales will cover the following themes: food intake, weight changes, digestive symptoms, taste disorders, pain and fatigue. The system will be able to monitor data changes and the response given will be adapted according to the severity of symptoms:
- No signs of seriousness: general prevention or treatment documents/advice: toxicity management, nutritional advices targeted on symptoms, on digestive problems, on appropriate physical activity.
- Presence of signs of seriousness: action to be taken and alert to the coordinating nurse, oncologist or dietician.
In case of an alert, the coordinating nurse will call the patient back and either manage the symptom, schedule a nutritional consultation to initiate nutritional management, or refer the patient to the oncologist.
| Study group | Role | What they receive |
|---|---|---|
| use of myDIET tool for nutritional management | Experimental | Patients will be followed up at regular intervals during neoadjuvant treatment, perioperatively and up to 6 months after the date of surgery (after completion of postoperative treatment). Receives: Other: myDIET software tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients starting adjuvant treatment within 2 months
proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery
Measured: 2 months after surgery
Secondary outcomes (27)
Adherence to the tool
Percentage of completed questionnaires
Measured: From inclusion and up to 6 months after surgery
Number of supportive care and emergency consultations initiated by the caregiver
Number of supportive care and emergency consultations initiated by the caregiver on the bases of questionnaires completed by patients
Measured: From inclusion and up to 6 months after surgery
Proportion of patients with malnutrition
Proportion of patients with malnutrition defined according to the criteria of the French National Authority for Health
Measured: From inclusion and up to 6 months after surgery
Evolution of body composition in L3 section (volumes)
Evolution of body composition based on body composition in L3 section on CT scan in volumes (cm2) at inclusion, after neoadjuvant treatment and 6 months after surgery.
Measured: From inclusion and up to 6 months after surgery
Evolution of body composition in L3 section (indexes)
Evolution of body composition based on body composition in L3 section on CT scan in indexes (cm2/m2) at inclusion, after neoadjuvant treatment and 6 months after surgery.
Measured: From inclusion and up to 6 months after surgery
Evolution of resting energy expenditure
Changes in resting energy expenditure (Kcal/day) will be measured at inclusion, at day 5-12 postoperatively, and at 1 month after surgery (before adjuvant treatment) with the measurement of basal metabolic rate quantified by indirect calorimetry (Kcal/day)
Measured: From inclusion and up to 1 month after surgery
Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day
The proportion of patients with dietary intakes > or equal to 30kcal/kg/day will be quantified during the dietary consultation at inclusion, at day 7 after surgery, at 1 month after surgery and 6 months after surgery.
Measured: From inclusion and up to 6 months after surgery
Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry
Theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry (kcal/day) will be quantified during the dietary consultation at inclusion, at day 7 after surgery, at 1 month after surgery and 6 months after surgery.
Measured: From inclusion and up to 6 months after surgery
Weight changes
Weight changes will be described by the weight in kg
Measured: From inclusion and up to 6 months after surgery
Brachial circumference changes
Brachial circumference will be described in cm
Measured: From inclusion and up to 6 months after surgery
Triceps skin fold changes
Triceps skin fold will be described in mm
Measured: From inclusion and up to 6 months after surgery
Initiation time for post-operative treatment
Initiation time for post-operative treatment will be defined as the time in days between the date of surgery and the date of the first course of post operative treatment
Measured: From surgery to date of post operative treatment initiation assessed up to 6 months after surgery
Proportion of patient with incomplete scheme of pre operative treatment
Proportion of patient with incomplete scheme of pre operative treatment and their causes will be described
Measured: From inclusion to surgery
Proportion of patient with incomplete scheme of post operative treatment
Proportion of patient with incomplete scheme of post operative treatment and their causes will be described
Measured: From surgery and up to 6 months after surgery
Proportion of patients with severe post operative complication
Proportion of patients with severe post operative complication will be described according to the occurence of a grade > III complication according to Clavien Dindo classification
Measured: From surgery up to 6 months after surgery
Tolerance to perioperative treatment
Tolerance to perioperative treatment will be assessed with self-assessment using myDIET questionnaires and nutritional consultations based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 classification.
Grades range from 1 to 5 and refer to the severity of the adverse event. A higher grade means a worse outcome.
Measured: From inclusion up to 6 months after surgery
Changes in food intake
Changes in food intake will be evaluated during treatment and the postoperative period (myDIET follow-up questionnaires).
Measured: From inclusion up to 6 months after surgery
Changes in SEFI (Easy Food Intake Score)
Changes in SEFI (Easy Food Intake Score) will be evaluated using visual scales (during treatment and the postoperative period (myDIET follow-up questionnaires).
SEFIs are assessed using visual scales ('analogue' or 'portions eaten'). With the visual analogue scale, the patients indicate the quantities they are currently eating using the cursor on the graduated scale from "nothing at all" = 0 to "as usual" = 10.
With the visual portions eatenscale , patients can use the cursor to indicate the portions eaten at their last meal (lunch or dinner).
Measured: From inclusion up to 6 months after surgery
Measurement of quality of life
Quality of life will be assessed with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This 30-item questionnaire is completed by the patient and includes five multi-item functional scales (physical, role, cognitive, emotional and social); eight symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, loss of appetite and constipation); and a global health scale. The score for each item ranges from 1 (not at all) to 4 (very much).
Measured: From inclusion and up to 6 months after surgery
Average lengh of hospital stay
The average lengh of hospital stay during surgery will be described in terms of the number of days spent in hospital
Measured: At the time of surgery
Recurrence free survival (RFS)
Recurrence free survival (RFS) will be definied as the duration in days between the date of inclusion and the date of radiologically documented relapse or death from any cause
Measured: From inclusion and up to the date of radiologically documented relapse or death from any cause, whichever came first, assessed up to 30 months
Overall survival (OS)
Overall survival (OS) will be defined as the time in days from date of the inclusion to the date of death from any cause
Measured: From inclusion and up to the date of death from any cause, assessed up to 30 months
Adherence to the physical activity program
Adherence to the physical activity program will be described by the number of weekly session declared by the patient
Measured: From inclusion and up to 6 months after surgery
Physical activity levels
Physical activity levels will be assessed using the International Physical Activity Questionnaire (short version). The questions ask how much time the patient has spent being physically active over the last 7 days (duration of activity in minutes or hours, and number of days of activity in days).
Measured: From inclusion and up to 6 months after surgery
Assessment of muscular function by the 6-min walk test
Assessment of muscular function will be assessed by the 6-min walk test (described in meters)
Measured: From inclusion and up to 6 months after surgery
Assessment of muscular function by muscular strength
Assessment of muscular function will be assessed by muscular strength measured with hand grip dynamometer (described in kg)
Measured: From inclusion and up to 6 months after surgery
Assessment of muscular function by the Five Times Sit to Stand Test
Assessment of muscular function will be assessed by the Five Times Sit to Stand Test (described in seconds)
Measured: From inclusion and up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start26 Apr 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm Phase II study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Funk-Debleds, MD, Principal investigator, Centre Léon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385691
- Sponsor's protocol ID
- ET22-145
- Acronym
- MyDIET
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
- ClinicalTrials.gov ID
- NCT06385691
- Acronym / sponsor ID
- MyDIET / ET22-145
- Conditions
- Gastric Cancer, Oesogastric Junction Cancer
- Keywords
- denutrition, software tool, physical activity, postoperative treatment, chemotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 26 Apr 2024 (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 prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.
Detailed description
Gastric cancer is the 3rd leading cause of cancer mortality worldwide, with a 5-year survival rate of less than 30%. In localised gastric cancer (GC) or cancer of the oesogastric junction (OGJ), the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy (5FU, Leucovorin, Oxaliplatin, Taxotere). However, up to 51% of patients have post-operative complications, and only 60% can benefit from post-operative chemotherapy (at least one course) initiated within 12 weeks of surgery, while 46% receive the full theoretical regimen.
An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis. Undernutrition and sarcopenia increase the occurrence of post-operative complications, length of stay and post-operative readmissions. Undernutrition is an independent risk factor for failure and/or incomplete adjuvant chemotherapy, with an impact on progression-free survival and overall survival. There is a high prevalence of undernutrition in patients with GC/OGJ, estimated at 53-60%, and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively.
Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications. Early multimodal management, combining nutrition, adapted physical activity and neoadjuvant chemotherapy, is therefore recommended and essential in the perioperative situation. To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer, the CLB teams have developed a computer interface (MyDIET) linked to the myCLB patient portal. This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment, and to prevent the onset or worsening of undernutrition.
For this reason, the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CG/OGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm Phase II study.
| Arm | Type | Receives |
|---|---|---|
| use of myDIET tool for nutritional management | Experimental | Other: myDIET software toolPatients will be followed up at regular intervals during neoadjuvant treatment, perioperatively and up to 6 months after the date of surgery (after completion of postoperative treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient 18 years of age or older at date of signing informed consent to participate;
- Histologically proven diagnosis of gastric adenocarcinoma or OGJ;
- Localized, resectable disease;
- Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
- Performance status (ECOG): 0-2;
Key exclusion criteria (11 listed)
- Other associated solid cancer or haemopathy;
- Presence of severe comorbidity (Charlson index > 9)
- Presence of unbalanced dysthyroidism;
- History of gastric, duodenal or esophageal surgery;
- Inability to comply with study requirements, including :
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 |
|---|---|---|
| myDIET software toolThe tool is based on self-questionnaires completed by the patient. They are mainly filled in using visual analogue scales (from 0-10) or grades of symptoms/toxicities (Grades 0 to 4), based on the CTCAE V5. These scales will cover the following themes: food intake, weight changes, digestive symptoms, taste disorders, pain and fatigue. The system will be able to monitor data changes and the response given will be adapted according to the severity of symptoms: * No signs of seriousness: general prevention or treatment documents/advice: toxicity management, nutritional advices targeted on symptoms, on digestive problems, on appropriate physical activity. * Presence of signs of seriousness: action to be taken and alert to the coordinating nurse, oncologist or dietician. In case of an alert, the coordinating nurse will call the patient back and either manage the symptom, schedule a nutritional consultation to initiate nutritional management, or refer the patient to the oncologist. | Other | use of myDIET tool for nutritional management |
Primary outcome
Proportion of patients starting adjuvant treatment within 2 months
Time frame: 2 months after surgery
proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery
27 secondary outcomes
Adherence to the tool
Time frame: From inclusion and up to 6 months after surgery
Number of supportive care and emergency consultations initiated by the caregiver
Time frame: From inclusion and up to 6 months after surgery
Proportion of patients with malnutrition
Time frame: From inclusion and up to 6 months after surgery
Evolution of body composition in L3 section (volumes)
Time frame: From inclusion and up to 6 months after surgery
Evolution of body composition in L3 section (indexes)
Time frame: From inclusion and up to 6 months after surgery
Evolution of resting energy expenditure
Time frame: From inclusion and up to 1 month after surgery
Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day
Time frame: From inclusion and up to 6 months after surgery
Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry
Time frame: From inclusion and up to 6 months after surgery
Weight changes
Time frame: From inclusion and up to 6 months after surgery
Brachial circumference changes
Time frame: From inclusion and up to 6 months after surgery
Triceps skin fold changes
Time frame: From inclusion and up to 6 months after surgery
Initiation time for post-operative treatment
Time frame: From surgery to date of post operative treatment initiation assessed up to 6 months after surgery
Proportion of patient with incomplete scheme of pre operative treatment
Time frame: From inclusion to surgery
Proportion of patient with incomplete scheme of post operative treatment
Time frame: From surgery and up to 6 months after surgery
Proportion of patients with severe post operative complication
Time frame: From surgery up to 6 months after surgery
Tolerance to perioperative treatment
Time frame: From inclusion up to 6 months after surgery
Changes in food intake
Time frame: From inclusion up to 6 months after surgery
Changes in SEFI (Easy Food Intake Score)
Time frame: From inclusion up to 6 months after surgery
Measurement of quality of life
Time frame: From inclusion and up to 6 months after surgery
Average lengh of hospital stay
Time frame: At the time of surgery
Recurrence free survival (RFS)
Time frame: From inclusion and up to the date of radiologically documented relapse or death from any cause, whichever came first, assessed up to 30 months
Overall survival (OS)
Time frame: From inclusion and up to the date of death from any cause, assessed up to 30 months
Adherence to the physical activity program
Time frame: From inclusion and up to 6 months after surgery
Physical activity levels
Time frame: From inclusion and up to 6 months after surgery
Assessment of muscular function by the 6-min walk test
Time frame: From inclusion and up to 6 months after surgery
Assessment of muscular function by muscular strength
Time frame: From inclusion and up to 6 months after surgery
Assessment of muscular function by the Five Times Sit to Stand Test
Time frame: From inclusion and up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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.
Pamela Funk-Debleds, MD principal investigator
Centre Léon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing myDIET software tool in people with Gastric Cancer and Oesogastric Junction Cancer, run by Centre Leon Berard at 1 site in France.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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 France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Funk-Debleds, MD (0469856020 ext. +33, pamela.funk-debleds@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients starting adjuvant treatment within 2 months (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.