Long-term Effects Secondary to Cancer Therapy in AdultsNCT04265638
Exercise Intervention in Adolescent and Young Adult Cancer Survivors
A study testing Exercise in people with Long-term Effects Secondary to Cancer Therapy in Adults and Pediatric Cancer, run by Indiana University at 3 sites in United States.
Trial summary
Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental… Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Long-term Effects Secondary to Cancer Therapy in Adults, Pediatric Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jun 2019to May 2024
- 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 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 15 and ≤ 39 years,
- History of cancer
- At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)
Who cannot join
- Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
- History of CNS tumor
- Down's Syndrome
- Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
- Neurological disorder
- Baseline exercise of 30 minutes per day three times a week already being performed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
NiCole Keith, PhD, 317-278-8438, nkeith@iupui.edu
- Recruiting
Riley Hospital for Children - Indiana University
Indianapolis, Indiana, 46202
NiCole Keith, PhD, 317-278-8438, nkeith@iupui.edu
- Recruiting
Indianapolis Healthplex
Indianapolis, Indiana, 46222
Adnan Hyder, 317-920-7400, ahyder@indianapolishealthplex.com
About this study
Official title: One-on-one Exercise Program in Adolescent and Young Adult Cancer Survivors With a Certified Clinical Cancer Exercise Specialist
Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors.
- Being tested
- Exercise
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
One on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire
The Participant Evaluation of Feasibility and Acceptability Questionnaire consists of 6 items arranged on a Likert scale ranging from 1- 5, and 4 additional open-ended questions designed to elicit information concerning the benefits and barriers to participating in the resistance exercise intervention.
Measured: weeks 12 and 24
Change of Balance Assessment
The BOT2 Balance subtests 5, Number 2: Walking forward on a line and Subtest 5, Number 7: Standing on One leg on a balance beam - Eyes Open will evaluate motor-control skills that are integral for maintaining posture when standing, walking, or reaching. This motor-area composite measures control and coordination of the large musculature that aids in posture and balance. Scores are assessed to determine stability dynamically and statically, on one leg and utilizing both legs, on a balance beam when the eyes are open for more than 10 seconds and if the patient can likely do so when the eyes are closed for about 5 to 10 seconds and also a twenty-four foot straight line.
Measured: baseline, weeks 6, 12, and 24
Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1)
The subject's VO2 Peak (mL-kg-1-min-1) will be used to assess the cardiovascular system.
Measured: baseline, weeks 6, 12, and 24
Change of Cardiovascular Systems - FEV1
The subject's forced expiratory volume in one second (FEV1) will be used to assess the cardiovascular system.
FEV1: Male = [0.0566 (ht in cm)] - [0.0233 (age)] - 4.91
Measured: baseline, weeks 6, 12, and 24
Change of Cardiovascular Systems - FCV
The subject's estimated forced vital capacity (FVC) will be used to assess the cardiovascular system.
FVC: Male = [0.0774 (ht in cm)] - [0.0212 (age)] - 7.75 Female = [0.0414 (ht in cm)] - [0.0232 (age)] - 2.2
Measured: baseline, weeks 6, 12, and 24
Change of Fatigue
The Revised Piper Fatigue Scale: Fatigue will be measured using the Piper Fatigue Inventory, which evaluates total cancer-related fatigue, as well as subscales of fatigue such as affective, behavior, cognitive, mood, and sensory. There are 4 individual subscales comprise 22 items with the average score representing total fatigue. The subscales are behavioral/severity (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Standardized alpha for the entire scale (n = 22 items) is 0.97, indicating that some redundancy still may exist among the items. The scale ranges from 0 to 10. A score of 0 indicates that the participant shows no signs of fatigue; a score from 1 to 3 indicates mild fatigue, 4-6 indicates moderate fatigue and a score greater than 7 indicates severe fatigue.
Measured: baseline, weeks 6, 12, and 24
Change of Neuropathy 15-17 year olds
Pediatric Total Neuropathy Score (Peds-TNS): A multidimensional instrumentused to measure peripheral neuropathy symptoms and signs in children from 15-17 years old. This instrument assesses proximal extension of numbness, tingling, and neuropathic pain, motor function, vibration and touch sensation, strength, tendon reflexes, dizziness. These parameters provide qualitative information on symptoms, nerve conduction and sensory tests on a scale of 0 for none to 4 for severe. The individual scores are added together to provide a single measure of neuropathy called a Total Neuropathy Score.
Measured: baseline, weeks 6, 12, and 24
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in one second (FEV1).
FEV1: Male = [0.0566 (ht in cm)] - [0.0233 (age)] - 4.91
Measured: baseline, weeks 6, 12, and 24
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in estimated forced vital capacity (FVC).
FVC: Male = [0.0774 (ht in cm)] - [0.0212 (age)] - 7.75 Female = [0.0414 (ht in cm)] - [0.0232 (age)] - 2.2
Measured: baseline, weeks 6, 12, and 24
Change of Cancer Therapy Fatigue
Functional Assessment of Cancer Therapy Fatigue Scale (FACIT-F) Brief: A questionnaire assessing fatigue and anemia-related concerns in people with cancer.
Measured: baseline, weeks 6, 12, and 24
Change of Neuropathy over 17 years of age
Total Neuropathy Score Clinical Evaluation (TNS): The best acknowledged method to assess the severity and changes in chemotherapy-induced peripheral neurotoxicity for individuals over 17. The TNSc consists of items with scores correlating significantly with the National Cancer Institute-Common Toxicity Criteria v. 2.0
Measured: baseline, weeks 6, 12, and 24
Secondary outcomes (8)
Depression - BDI
Beck Depression Inventory (BDI): The BDI is a 21-item self-report rating inventory for characteristics of depression with ratings from 0 to 3, with 3 being the most intense. The BDI is for individuals 19 and older.
Measured: Baseline, weeks 12 and 24.
Depression - CDI
Title: Children's Depression Inventory (CDI): The CDI is a 27-item scale that is self-rated and symptom-oriented. It is a validated test for children 18 and under. There are 27 items with scores ranging from 0-2, so there is a possible total score of 0-54, with 0 being no depression to 54 being the worst. The non-clinical cut off score is 19-20, which will be the one we are using.
Measured: Baseline, weeks 12 and 24.
Beck Anxiety Inventory
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs[4] are:
0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety
Measured: Baseline, weeks 12 and 24.
Measure health-related Quality of Life
Pediatric Quality of Life Inventory (PedsQL 4.0): The PedsQL is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL integrates generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL generic core scales and disease-specific scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. This measure is tailored to 5 different age groups: however, we will only use the section designed for teens (13-18) which is made up of 23 items comprising 4 dimensions. Ferrans \& Powers Quality of Life Index: Total quality of life will be measured using the Ferrans and Powers Quality of Life Index Version III and is a 66-question index designed to evaluate social, psychological, family, and health satisfaction. This assessment is valid for ages 18 and up.
Measured: Baseline, weeks 12 and 24.
Healthy Days Core Module (CDC HRQOL-4
The HRQOL is a 4-question assessment of overall health, both physical and mental health. The questionnaire is scored as follows: First unhealthy days are calculated as an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. The score for obtaining unhealthy days is done by combining the responses to questions 2 and 3 to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days.
Measured: baseline, weeks 6, 12, and 24
Pain scale
Visual Analogue Scale (VAS): The VAS is a validated pain measurement for individuals age seven and older. The scale is a single line with one end denoting no pain and the other, the worst pain possible. The scale was validated in 1976 with a reliability score of 0.94. The VAS is a scale of 100-mm and ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain81
Measured: baseline, weeks 6, 12, and 24
Pittsburgh Sleep Quality Index Survey
The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 ques-tions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Measured: baseline, weeks 6, 12, and 24
Adverse Event Pain Assessment
The NCI Common Terminology Criteria for Adverse Events (CTCAE) V4.02: The NCI Common Terminology Criteria for Adverse Events Version 4.02 is a descriptive scale that grades adverse events occurring after chemotherapy in cancer patients and explores the quality of life (QOL) findings among post therapy cancer patients. A grading (severity) scale is provided for each AE term. The grading scale is 0-5 with Grade 0: no signs or symptoms of the Adverse Event to Grade 5: death.
Measured: baseline, weeks 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start5 Jun 2019
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-term Effects Secondary to Cancer Therapy in AdultsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NiCole Keith, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265638
- Sponsor's protocol ID
- IUSCC-0696
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-on-one Exercise Program in Adolescent and Young Adult Cancer Survivors With a Certified Clinical Cancer Exercise Specialist
- ClinicalTrials.gov ID
- NCT04265638
- Acronym / sponsor ID
- IUSCC-0696
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 11 Feb 2020 (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.
Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age ≥ 15 and ≤ 39 years,
- History of cancer
- At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)
Key exclusion criteria (6 listed)
- Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
- History of CNS tumor
- Down's Syndrome
- Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
- Neurological disorder
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 |
|---|---|---|
| ExerciseOne on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks. | Behavioural | Exercise |
Primary outcome
Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire
Time frame: weeks 12 and 24
The Participant Evaluation of Feasibility and Acceptability Questionnaire consists of 6 items arranged on a Likert scale ranging from 1- 5, and 4 additional open-ended questions designed to elicit information concerning the benefits and barriers to participating in the resistance exercise intervention.
Change of Balance Assessment
Time frame: baseline, weeks 6, 12, and 24
The BOT2 Balance subtests 5, Number 2: Walking forward on a line and Subtest 5, Number 7: Standing on One leg on a balance beam - Eyes Open will evaluate motor-control skills that are integral for maintaining posture when standing, walking, or reaching. This motor-area composite measures control and coordination of the large musculature that aids in posture and balance. Scores are assessed to determine stability dynamically and statically, on one leg and utilizing both legs, on a balance beam when the eyes are open for more than 10 seconds and if the patient can likely do so when the eyes are closed for about 5 to 10 seconds and also a twenty-four foot straight line.
Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1)
Time frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to assess the cardiovascular system.
Change of Cardiovascular Systems - FEV1
Time frame: baseline, weeks 6, 12, and 24
The subject's forced expiratory volume in one second (FEV1) will be used to assess the cardiovascular system. FEV1: Male = [0.0566 (ht in cm)] - [0.0233 (age)] - 4.91
Change of Cardiovascular Systems - FCV
Time frame: baseline, weeks 6, 12, and 24
The subject's estimated forced vital capacity (FVC) will be used to assess the cardiovascular system. FVC: Male = [0.0774 (ht in cm)] - [0.0212 (age)] - 7.75 Female = [0.0414 (ht in cm)] - [0.0232 (age)] - 2.2
Change of Fatigue
Time frame: baseline, weeks 6, 12, and 24
The Revised Piper Fatigue Scale: Fatigue will be measured using the Piper Fatigue Inventory, which evaluates total cancer-related fatigue, as well as subscales of fatigue such as affective, behavior, cognitive, mood, and sensory. There are 4 individual subscales comprise 22 items with the average score representing total fatigue. The subscales are behavioral/severity (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Standardized alpha for the entire scale (n = 22 items) is 0.97, indicating that some redundancy still may exist among the items. The scale ranges from 0 to 10. A score of 0 indicates that the participant shows no signs of fatigue; a score from 1 to 3 indicates mild fatigue, 4-6 indicates moderate fatigue and a score greater than 7 indicates severe fatigue.
Change of Neuropathy 15-17 year olds
Time frame: baseline, weeks 6, 12, and 24
Pediatric Total Neuropathy Score (Peds-TNS): A multidimensional instrumentused to measure peripheral neuropathy symptoms and signs in children from 15-17 years old. This instrument assesses proximal extension of numbness, tingling, and neuropathic pain, motor function, vibration and touch sensation, strength, tendon reflexes, dizziness. These parameters provide qualitative information on symptoms, nerve conduction and sensory tests on a scale of 0 for none to 4 for severe. The individual scores are added together to provide a single measure of neuropathy called a Total Neuropathy Score.
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1
Time frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in one second (FEV1). FEV1: Male = [0.0566 (ht in cm)] - [0.0233 (age)] - 4.91
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC
Time frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in estimated forced vital capacity (FVC). FVC: Male = [0.0774 (ht in cm)] - [0.0212 (age)] - 7.75 Female = [0.0414 (ht in cm)] - [0.0232 (age)] - 2.2
Change of Cancer Therapy Fatigue
Time frame: baseline, weeks 6, 12, and 24
Functional Assessment of Cancer Therapy Fatigue Scale (FACIT-F) Brief: A questionnaire assessing fatigue and anemia-related concerns in people with cancer.
Change of Neuropathy over 17 years of age
Time frame: baseline, weeks 6, 12, and 24
Total Neuropathy Score Clinical Evaluation (TNS): The best acknowledged method to assess the severity and changes in chemotherapy-induced peripheral neurotoxicity for individuals over 17. The TNSc consists of items with scores correlating significantly with the National Cancer Institute-Common Toxicity Criteria v. 2.0
8 secondary outcomes
Depression - BDI
Time frame: Baseline, weeks 12 and 24.
Depression - CDI
Time frame: Baseline, weeks 12 and 24.
Beck Anxiety Inventory
Time frame: Baseline, weeks 12 and 24.
Measure health-related Quality of Life
Time frame: Baseline, weeks 12 and 24.
Healthy Days Core Module (CDC HRQOL-4
Time frame: baseline, weeks 6, 12, and 24
Pain scale
Time frame: baseline, weeks 6, 12, and 24
Pittsburgh Sleep Quality Index Survey
Time frame: baseline, weeks 6, 12, and 24
Adverse Event Pain Assessment
Time frame: baseline, weeks 6, 12, and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Long-term Effects Secondary to Cancer Therapy in Adults and Pediatric Cancer, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NiCole Keith, PhD (317-278-8438, nkeith@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire (time frame: weeks 12 and 24). The study lists 11 primary outcomes in all. 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 NCT04265638, 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 28 Nov 2023.