RadiodermatitisLABRANCT03924011
Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy
A study testing Photobiomodulation therapy (PBMT) in people with Radiodermatitis and Breast Cancer, run by Hasselt University at 2 sites in Belgium.
Trial summary
Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis, Breast Cancer
- What is being tested?
- Photobiomodulation therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jul 2020to 1 Jun 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- 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 at Ziekenhuis Oost-Limburg, Genk:
- Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)
Who cannot join
- Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium
- 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 to ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
- Known or suspected non-compliance, drug or alcohol abuse
Show all 13Show fewer
- Inability to follow the procedures of the study, e.g. due to language problems, psyschological disorders, dementia, etc. of the participant
- Seizure
- Disorders triggered by lighttake anticoagulants
- Hemorrhagic diatheses
- Pregnancy
- Suspected of carrying serious infectious disease
- HIV positive history
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg Campus St.-Jan
Genk, Limburg, 3600
Jessa Ziekenhuis
Hasselt, 3500
About this study
Official title: The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial
Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.
Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.
Read more
Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.
The results of this project will support the implementation of PBMT into the standard RD skincare program.
- Conditions
- Radiodermatitis, Breast Cancer
- Being tested
- Photobiomodulation therapy (PBMT), Sham laser
- Keywords
- Radiodermatitis, Breast cancer, Radiotherapy, Photobiomodulation therapy, Low-level light therapy, Skin diseases, Radiation injuries, Wounds and injuries, Oncology
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Skin Diseases, Radiation Injuries, Wounds and Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (PBMT)Device
Also called Low-level light therapy (LLLT)
PBMT sessions will be planned 2x/week after RT.
Sham laserDevice
Sham laser sessions will be applied 2x/week after RT.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy Receives: Device: Sham laser |
| Treatment group | Experimental | Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy Receives: Device: Photobiomodulation therapy (PBMT) |
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) 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: week 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) 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: week 2
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) 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: week 3
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) 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: week 4
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) 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: week 5
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) 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: week 6
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: week 1
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Measured: week 2
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Measured: week 3
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Measured: week 4
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)
Measured: week 5
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)
Measured: week 6
Secondary outcomes (12)
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 1
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 2
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 3
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 4
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 5
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Measured: week 6
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 1
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 2
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 3
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 4
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 5
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Jul 2020
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Prof. dr. Jeroen Mebis, Hasselt University
- Investigators
- Jolien Robijns, PhD, Study director, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924011
- Sponsor's protocol ID
- Labra-001
- Acronym
- LABRA
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03924011
- Acronym / sponsor ID
- LABRA / Labra-001
- Conditions
- Radiodermatitis, Breast Cancer
- Keywords
- Radiodermatitis, Breast cancer, Radiotherapy, Photobiomodulation therapy, Low-level light therapy, Skin diseases, Radiation injuries, Wounds and injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Ziekenhuis Oost-Limburg
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 Apr 2019 (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.
Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.
Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.
Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.
The results of this project will support the implementation of PBMT into the standard RD skincare program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: Sham laserReceives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
| Treatment group | Experimental | Device: Photobiomodulation therapy (PBMT)Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature
- 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 at Ziekenhuis Oost-Limburg, Genk:
- Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)
Key exclusion criteria (13 listed)
- Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium
- 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 to 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 |
|---|---|---|
| Photobiomodulation therapy (PBMT)Also: Low-level light therapy (LLLT)PBMT sessions will be planned 2x/week after RT. | Device | Treatment group |
| Sham laserSham laser sessions will be applied 2x/week after RT. | Device | Control group |
Primary outcome
Radiation Dermatitis Grade
Time frame: week 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) 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: week 2
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) 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: week 3
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) 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: week 4
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) 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: week 5
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) 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: week 6
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) 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: week 1
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
Time frame: week 2
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Radiation Dermatitis Assessment
Time frame: week 3
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Radiation Dermatitis Assessment
Time frame: week 4
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Radiation Dermatitis Assessment
Time frame: week 5
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)
Radiation Dermatitis Assessment
Time frame: week 6
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)
12 secondary outcomes
Pain evaluation: VAS
Time frame: week 1
Pain evaluation: VAS
Time frame: week 2
Pain evaluation: VAS
Time frame: week 3
Pain evaluation: VAS
Time frame: week 4
Pain evaluation: VAS
Time frame: week 5
Pain evaluation: VAS
Time frame: week 6
Quality of life assessment
Time frame: week 1
Quality of life assessment
Time frame: week 2
Quality of life assessment
Time frame: week 3
Quality of life assessment
Time frame: week 4
Quality of life assessment
Time frame: week 5
Quality of life assessment
Time frame: week 6
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 1 Sep 2021.
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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.
Jolien Robijns, PhD study director
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (PBMT) in people with Radiodermatitis and Breast Cancer, run by Hasselt University at 2 sites 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 5 inclusion and 13 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: week 1). The study lists 12 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 1 Sep 2021.