Breast CancerTRANSDERMISNCT02443493
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
A study testing Low-level laser and radiotherapy in people with Breast Cancer, run by Hasselt University at 1 site in Belgium.
Trial summary
Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD). Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low-level laser and radiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Jun 2017
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
- Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
- Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
- Signed informed consent
Who cannot join
- Previous irradiation to the same breast
- Metastatic disease
- Concurrent chemotherapy
- Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).
Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Low-level laser, sham laser, radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laserDevice
Also called LLLT
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
sham laserDevice
Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) Receives: Device: Low-level laser; Radiation: radiotherapy |
| Control group | Sham comparator | Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) Receives: Device: sham laser; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dermatitis Grade
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Measured: day 1
Radiation Dermatitis Grade
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Measured: day 20
Radiation Dermatitis Grade
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Measured: day 33
Radiation Dermatitis Grade
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Measured: day 40
Radiation Dermatitis Grade
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Measured: day 54
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: day 1
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: day 20
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: day 33
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: day 40
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: day 54
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Measured: day 1
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Measured: day 20
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Measured: day 33
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Measured: day 40
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Measured: day 54
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: day 1
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: day 20
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: day 33
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: day 40
Objective measurement of trans epidermal water loss of the skin
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: day 54
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: day 1
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: day 20
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: day 33
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: day 40
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: day 54
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Measured: day 1
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Measured: day 20
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Measured: day 33
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Measured: day 40
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Measured: day 54
Secondary outcomes (20)
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Measured: day 1
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Measured: day 20
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Measured: day 33
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Measured: day 40
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Measured: day 54
Quality of life
Health-related quality of life measure specific to skin diseases
Measured: day 1
Quality of life
Health-related quality of life measure specific to skin diseases
Measured: day 20
Quality of life
Health-related quality of life measure specific to skin diseases
Measured: day 33
Quality of life
Health-related quality of life measure specific to skin diseases
Measured: day 40
Quality of life
Health-related quality of life measure specific to skin diseases
Measured: day 54
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: day 1
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: day 20
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: day 33
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: day 40
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: day 54
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Measured: day 1
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Measured: day 20
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Measured: day 33
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Measured: day 40
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Measured: day 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Prof. dr. Jeroen Mebis, Hasselt University
- Investigators
- Jeroen Mebis, prof. dr., Principal investigator, Universiteit Hasselt/ Jessa ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443493
- Sponsor's protocol ID
- 15.38/onco15.06
- Acronym
- TRANSDERMIS
- Status last verified
- Jul 2019
- First submitted
- 11 May 2015
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02443493
- Acronym / sponsor ID
- TRANSDERMIS / 15.38/onco15.06
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).
Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Low-level laser, Radiation: radiotherapyTreatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) |
| Control group | Sham comparator | Device: sham laser, Radiation: radiotherapyControl group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
- Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
- Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
- Signed informed consent
Key exclusion criteria (4 listed)
- Previous irradiation to the same breast
- Metastatic disease
- Concurrent chemotherapy
- Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
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 |
|---|---|---|
| Low-level laserAlso: LLLTLow-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care. | Device | Treatment group |
| sham laserSham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care. | Device | Control group |
| radiotherapy | Radiation | Control group, Treatment group |
Primary outcome
Radiation Dermatitis Grade
Time frame: day 1
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Radiation Dermatitis Grade
Time frame: day 20
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Radiation Dermatitis Grade
Time frame: day 33
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Radiation Dermatitis Grade
Time frame: day 40
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Radiation Dermatitis Grade
Time frame: day 54
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Radiation Dermatitis Assessment
Time frame: day 1
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
Time frame: day 20
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
Time frame: day 33
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
Time frame: day 40
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
Time frame: day 54
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of trans epidermal water loss of the skin
Time frame: day 1
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Time frame: day 20
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Time frame: day 33
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Time frame: day 40
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Time frame: day 54
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of the skin hydration
Time frame: day 1
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Time frame: day 20
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Time frame: day 33
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Time frame: day 40
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of trans epidermal water loss of the skin
Time frame: day 54
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of degree of erythema of the skin
Time frame: day 1
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Time frame: day 20
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Time frame: day 33
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Time frame: day 40
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Time frame: day 54
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Time frame: day 1
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Time frame: day 20
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Time frame: day 33
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Time frame: day 40
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Time frame: day 54
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
20 secondary outcomes
Pain
Time frame: day 1
Pain
Time frame: day 20
Pain
Time frame: day 33
Pain
Time frame: day 40
Pain
Time frame: day 54
Quality of life
Time frame: day 1
Quality of life
Time frame: day 20
Quality of life
Time frame: day 33
Quality of life
Time frame: day 40
Quality of life
Time frame: day 54
Satisfaction with therapy
Time frame: day 1
Satisfaction with therapy
Time frame: day 20
Satisfaction with therapy
Time frame: day 33
Satisfaction with therapy
Time frame: day 40
Satisfaction with therapy
Time frame: day 54
moist desquamation
Time frame: day 1
moist desquamation
Time frame: day 20
moist desquamation
Time frame: day 33
moist desquamation
Time frame: day 40
moist desquamation
Time frame: day 54
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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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.
Jeroen Mebis, prof. dr. principal investigator
Universiteit Hasselt/ Jessa ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser and radiotherapy in people with Breast Cancer, run by Hasselt University at 1 site in Belgium.
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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dermatitis Grade (time frame: day 1). The study lists 30 primary outcomes in all. 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 26 Jul 2019.