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Physical ActivityNCT05887401

Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

A study testing Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red) in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Physical Activity, Neoplasms, Cancer
What is being tested?
Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
2 Oct 2023to 30 Sep 2024
Phase
Interventional
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 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Current age 18-39 years at the time of consent
  • Diagnosed with invasive cancer malignancy between the ages of 15-39 years
  • Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers
  • Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
  • No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
  • Not currently meeting guideline recommendations of 150 minutes/week moderate to vigorous physical activity (self-report) and guideline recommendations for fruit and vegetable consumption (self-report)
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  • Have the ability to read, write and speak English
  • Have access to the Internet on at least a weekly basis
  • Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
  • Have smartphone with internet access and text messaging plan
  • Be willing to be randomized to any condition

Who cannot join

  • History of heart attack or stroke within past 6 months
  • Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
  • Health problems which preclude ability to walk for physical activity
  • Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency
  • Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa)
  • Plans for major surgery (e.g., breast reconstruction) during the study time frame
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  • Current participation in another physical activity or weight control program
  • Currently using prescription weight loss medications
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity
  • Currently consuming > 5 servings of fruits and vegetables/day.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.

Read the detailed description

There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.

Being tested
Core Intervention, Simplified Dietary Monitoring (Green), Simplified Dietary Monitoring (Red), Nutrition Goals (Yes), Nutrition Goals (No)
Medical subject headings
Motor Activity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Core InterventionBehavioural

    The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.

  • Simplified Dietary Monitoring (Green)Behavioural

    Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.

  • Simplified Dietary Monitoring (Red)Behavioural

    Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

  • Nutrition Goals (Yes)Behavioural

    Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.

  • Nutrition Goals (No)Behavioural

    Participant will not be assigned a personalized weekly nutrition goal.

  • Supportive Text Messages (Yes)Behavioural

    Participant will receive up to 5 supportive text-messages from the study staff per week.

  • Supportive Text Messages (No)Behavioural

    Participant will not receive supportive text-messages.

  • Lesson Delivery (Once)Behavioural

    All behavioral lessons will be made available to participant simultaneously.

  • Lesson Delivery (Weekly)Behavioural

    A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.

Study groups in NCT05887401
Study groupRoleWhat they receive
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons OnceExperimentalCore + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly LessonsExperimentalCore + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons OnceExperimentalCore + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly LessonsExperimentalCore + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons OnceExperimentalCore + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly LessonsExperimentalCore + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons OnceExperimentalCore + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly LessonsExperimentalCore + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons OnceExperimentalCore + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly LessonsExperimentalCore + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons OnceExperimentalCore + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly LessonsExperimentalCore + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons OnceExperimentalCore + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly LessonsExperimentalCore + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons OnceExperimentalCore + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly LessonsExperimentalCore + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Receives: Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual Rate

    Number of participants who agreed to participate divided by the number of months of recruitment.

    Measured: End of study enrollment period (7 months).

  2. Participation Rate

    Percentage of consented participants who were randomized.

    Measured: End of study enrollment period (7 months).

  3. Retention Rate

    Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.

    Measured: 3 months

Secondary outcomes (14)
  1. Acceptability: How Satisfied Are You Overall With the Program You Received?

    1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability

    Measured: 3 months

  2. Adherence to Physical Activity Monitoring.

    Number of days physical activity tracked, as measured by Fitbit.

    Measured: Through study completion, 3 months.

  3. Adherence to Diet Self-monitoring

    Number of days of complete dietary tracking.

    Measured: Through study completion, 3 months.

  4. Moderate-to-vigorous Physical Activity (Objective)

    Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.

    Measured: Baseline, 3 months.

  5. Moderate-to-vigorous Physical Activity (Self-report)

    Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.

    Measured: Baseline, 3 months.

  6. Dietary Intake: Healthy Eating Index (HEI)

    Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.

    Measured: Baseline, 3 months

  7. Weight (kg)

    Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).

    Measured: Baseline, 3 months

  8. Fried Physical Frailty : FRAIL Index

    The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.

    Measured: Baseline, 3 Months

  9. Health-related Quality of Life: AYA PROMIS PRO Core Battery

    Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.

    Measured: Baseline, 3 months

  10. Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)

    Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.

    Measured: Baseline, 3 months

  11. Competence for Exercise and Nutrition

    Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.

    Measured: Baseline, 3 months

  12. Self-efficacy for Exercise and Nutrition

    Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.

    Measured: Baseline, 3 months

  13. Self-Regulation for Exercise and Nutrition

    Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.

    Measured: Baseline, 3 months

  14. Autonomy Support

    Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.

    Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start2 Oct 2023
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

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
Factorial
Model description
This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887401
Sponsor's protocol ID
LCCC2233
Other IDs
T32CA057726
Status last verified
Nov 2025
First submitted
24 May 2023
Last updated
24 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Core Intervention, Simplified Dietary Monitoring (Green) and Simplified Dietary Monitoring (Red) in people with Physical Activity and Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. 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 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?

Yes. Results are posted in the registry (first posted 24 Dec 2025). 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?

Accrual Rate (time frame: End of study enrollment period (7 months).). The study lists 3 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 24 Dec 2025.

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