Trial · NCT07884721
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Blood Glucose Levels During Fasting-Mimicking Diet Cycles | Baseline and before and after each 4-day FMD cycle, from Cycle 1 through Cycle 8 | Blood glucose levels measured by participant self-monitoring at baseline and before and after each fasting-mimicking diet (FMD) cycle. |
| Secondary | Adverse Events Related to the FASTEN Intervention | From initiation of the FASTEN intervention at Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks). | Incidence of adverse events related to the FASTEN intervention, as assessed by the investigator and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. |
| Secondary | Patient Satisfaction With Fasten Onco | After completion of the third Fasten Onco cycle and at completion of Fasten Onco use following Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks). | Patient satisfaction with Fasten Onco assessed using a study-specific 5-point Likert scale ranging from 0 (very dissatisfied) to 4 (very satisfied), with higher scores indicating greater satisfaction. |
| Secondary | Prognostic Factors for Event-Free Survival | From randomization through study completion, up to 3 years | Assessment of the association between prognostic factors and event-free survival (EFS). Prognostic factors evaluated include age, body mass index (BMI), disease stage, node status, tumor-infiltrating lymphocytes at baseline and surgery, Ki-67 grade and proliferation at baseline and surgery, and other identified prognostic factors. |
| Secondary | Tumor-Infiltrating Lymphocytes | Baseline and surgery, when available | Evolution of tumor-infiltrating lymphocyte levels during the study, when available. |
| Secondary | Change From Baseline in Body Mass Index | Baseline through study completion, up to 3 years | Absolute change from baseline in body mass index (BMI), measured in kilograms per square meter (kg/m²), during the study, including changes during and between Fasten Onco active fasting-mimicking diet days. |
| Secondary | Cumulative Administered Dose of Neoadjuvant Treatment | From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks | Total administered dose of neoadjuvant treatment received by each participant during the neoadjuvant treatment period. |
| Other | Dose Intensity of Neoadjuvant Treatment | From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks | Dose intensity calculated as the total administered dose as a proportion of the total planned dose. |
| Other | Number of Neoadjuvant Treatment Cycles Received | From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks | Number of neoadjuvant treatment cycles received by each participant. |
| Other | Number of Neoadjuvant Treatment Dose Delays | From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks | Number of dose delays occurring during neoadjuvant treatment. |
| Other | Neoadjuvant Treatment Discontinuation | From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks | Number of participants who permanently discontinue neoadjuvant treatment before planned completion. Reasons for discontinuation will be recorded. |
| Other | Blood Ketone Levels During Fasting-Mimicking Diet Cycles | Baseline and before and after each 4-day FMD cycle, from Cycle 1 through Cycle 8 | Blood ketone levels measured by participant self-monitoring at baseline and before and after each fasting-mimicking diet (FMD) cycle. |
| Other | Proportion of Fasting-Mimicking Diet Cycles Completed | From Cycle 1 through Cycle 8; each FMD cycle lasts 4 days | Proportion of fasting-mimicking diet (FMD) cycles completed relative to the number of neoadjuvant treatment cycles received by each participant. |
| Other | Duration of Fasten Onco Application Use | From initiation of Fasten Onco at Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks). | Duration of use of the Fasten Onco application by each participant, measured in days. |
| Other | Time Spent Using the Fasten Onco Application | From Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks). | Total time spent using the Fasten Onco application by each participant during the neoadjuvant treatment period, measured in minutes. |
| Other | Accuracy of Fasten Onco Synchronization With Neoadjuvant Treatment | From Cycle 1 through Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks). | Proportion of Fasten Onco fasting-mimicking diet cycles correctly synchronized with the corresponding neoadjuvant treatment cycles. |
| Other | Investigator Satisfaction With Fasten Onco | At completion of Cycle 8 for the last participant at each study center (treatment cycles generally administered every 21 days; approximately 24 weeks after Cycle 1 for that participant). | Investigator satisfaction with Fasten Onco assessed using a 5-point Likert scale ranging from 0 (very dissatisfied) to 4 (very satisfied), with higher scores indicating greater satisfaction. |
| Other | Time Required for Patient Registration in Fasten Onco | At baseline, during initial participant registration in Fasten Onco, before initiation of Cycle 1. | Time spent by the oncologist to register a participant in Fasten Onco. |
| Other | Usability of Fasten Onco Assessed With the French System Usability Scale | After completion of the third Fasten Onco cycle (approximately 9 weeks after initiation, if aligned with the 21-day neoadjuvant treatment cycles) | Usability of Fasten Onco assessed using the French version of the System Usability Scale (F-SUS). The F-SUS consists of 10 items and provides a total score ranging from 0 to 100, with higher scores indicating better perceived usability. |
| Other | Prognostic Factors for Overall Survival | From randomization through study completion, up to 3 years | Assessment of the association between prognostic factors and overall survival (OS). Prognostic factors evaluated include age, body mass index (BMI), disease stage, node status, tumor-infiltrating lymphocytes at baseline and surgery, Ki-67 grade and proliferation at baseline and surgery, and other identified prognostic factors. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07884721/registered?page=2