Non-small Cell Lung CancerCacheMireNCT02968979
Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.
An observational study of Non-small Cell Lung Cancer and Cachexia, run by Chugai Pharma France at 1 site in France.
Trial summary
The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Cachexia
- How many people
- 539 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or in-patient hospitalization.
Who may be able to join
- Patient 18 years of age and older
- Patient with NSCLC
- Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium
- Patient able to complete a self-assessment questionnaire
Who cannot join
- Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium
- Patient with a complete resection of an early stage NSCLC
- History of head and neck cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.
The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).
Read the detailed description
This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.
The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.
The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).
This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.
- Conditions
- Non-small Cell Lung Cancer, Cachexia
- Keywords
- Cachexia, Non-Small Cell Lung cancer, Anorexia, Malnutrition
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cachexia, Anorexia, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Cachexia According to Modified Fearon Criteria
Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.
A patient was considered to have cachexia if he/she had:
- Weight loss >5% in the last 6 months prior to inclusion or
- BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or
- Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
Measured: Day1
Secondary outcomes (24)
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Percentage of the different stages of cachexia at inclusion.
The different stages of cachexia used the following classification:
- No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia
- The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia
- Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
- Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
Measured: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
Measured: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Percentage of the different stages of cachexia according to the NSCLC histology
Measured: Day 1
Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
Percentage of patients with sarcopenia in the general NSCLC patients with cachexia
Measured: Day 1
Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:
Measured: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:
- EGRF, ALK, ROS1, BRAF or HER2
- K-RAS
- No mutation
Measured: Day 1
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
NSCLC patients. 84 patients with missing data
Measured: Day 1
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
- Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Blood glucose abnormalities according to the different stages of cachexia at inclusion
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
neutrophil/lymphocyte ratio
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
CRP level
Measured: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
fibrinogen level
Measured: Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales
Measured: Day 1
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Three levels of physical activity are defined:
- - Low
- No activity is reported OR
- An activity is reported but does not reach moderate or high levels.
- - Moderate Corresponds to one of the following 3 criteria:
- 3 or more days of intense activity lasting at least 20 min per day OR
- 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR
- 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week
- - High
Corresponds to one of the following 2 criteria:
- Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR
- 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week
Measured: Day 1
Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
Pharmacological treatment of cachexia or associated symptoms: Yes / No
Measured: Day 1
Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
Non-pharmacological treatment of cachexia or associated symptoms: Y/N
Measured: Day 1
Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
Measured: Day 1
Number of Participants With Diabetes Treatments
Diabetes treatments : Yes/No
Measured: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia
- Proportion of patients with cachexia according to the subjective assessment of the clinician
- Proportion of patients with cachexia according to the Fearon criteria
Measured: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia
- Proportion of patients with anorexia according to the subjective assessment of the clinician
- Proportion of patients with anorexia according to the Ingesta VAS
- Proportion of patients with anorexia according to the AC/S-FAACT module score
- Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"
Measured: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition
- Proportion of patients with severe malnutrition according to the subjective assessment of the clinician
- Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharma France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- French College of General Hospital Pneumologists (CPHG), French-Speaking Association of Supportive Care in Cancer (AFSOS), ITEC Services
- Responsible party
- Sponsor
- Investigators
- Luz Bobadilla, MD, Study director, Chugai Pharma France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968979
- Sponsor's protocol ID
- CPF-ANA-001
- Acronym
- CacheMire
- Status last verified
- Sep 2019
- First submitted
- 17 Nov 2016
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PubMed 21296615
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT02968979
- Acronym / sponsor ID
- CacheMire / CPF-ANA-001
- Conditions
- Non-small Cell Lung Cancer, Cachexia
- Keywords
- Cachexia, Non-Small Cell Lung cancer, Anorexia, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Chugai Pharma FranceIndustry (pharma, biotech, devices)
- Collaborators
- French College of General Hospital Pneumologists (CPHG), French-Speaking Association of Supportive Care in Cancer (AFSOS), ITEC Services
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).
Detailed description
This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.
The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.
The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).
This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or in-patient hospitalization.
Key inclusion criteria (4 listed)
- Patient 18 years of age and older
- Patient with NSCLC
- Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium
- Patient able to complete a self-assessment questionnaire
Key exclusion criteria (3 listed)
- Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium
- Patient with a complete resection of an early stage NSCLC
- History of head and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Cachexia According to Modified Fearon Criteria
Time frame: Day1
Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity. A patient was considered to have cachexia if he/she had: * Weight loss >5% in the last 6 months prior to inclusion or * BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or * Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
24 secondary outcomes
Frequency of the Different Stages of Cachexia in the General NSCLC Population
Time frame: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
Time frame: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
Time frame: Day 1
Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
Time frame: Day 1
Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
Time frame: Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
Time frame: Day 1
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
Time frame: Day 1
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
Time frame: Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
Time frame: Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia.
Time frame: Day 1
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
Time frame: Day 1
Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
Time frame: Day 1
Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
Time frame: Day 1
Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
Time frame: Day 1
Number of Participants With Diabetes Treatments
Time frame: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia
Time frame: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia
Time frame: Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21296615Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luz Bobadilla, MD study director
Chugai Pharma France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Cachexia, run by Chugai Pharma France 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 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Cachexia According to Modified Fearon Criteria (time frame: Day1). 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 NCT02968979, 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 24 Sep 2019.