Trial · NCT07884721
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in FACIT-Fatigue Total Score | Baseline to Day 7 after initiation of Cycle 8 of neoadjuvant treatment | Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score. The FACIT-Fatigue is a 13-item questionnaire assessing fatigue and its impact on daily activities and functioning. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The primary comparison will assess the difference in change from baseline between the FASTEN Group and the Standard of Care Group. |
| Secondary | Change From Baseline in FACIT-Fatigue Total Score and Subscores Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score and subscores during the neoadjuvant treatment period. The FACIT-Fatigue is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning. |
| Secondary | Time to Definitive Fatigue Worsening | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥6 points out of 52 in the FACIT-Fatigue total score compared with baseline, with no subsequent improvement or deterioration \<6 points until the end of the study, or in a participant who drops out after a ≥6-point decrease resulting in missing data or death. |
| Secondary | FACIT-Fatigue Severity Category | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | FACIT-Fatigue severity categorized as severe (total score ≤34) or non-severe (total score \>34), including shifts from baseline. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning. |
| Secondary | Change From Baseline in FACT-G Total Score at Cycle 8 | Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life. |
| Secondary | Change From Baseline in FACT-G Total Score Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score during the neoadjuvant treatment period. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life. |
| Secondary | Change From Baseline in FACT-G Domain Scores at Cycle 8 | Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being. |
| Secondary | Change From Baseline in FACT-G Domain Scores Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores during the neoadjuvant treatment period: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being. |
| Secondary | Time to Definitive FACT-G Deterioration | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥5 points out of 108 in FACT-G total score compared with baseline, with no subsequent improvement or deterioration \<5 points until the end of the study, or in a participant who drops out after a ≥5-point decrease resulting in missing data or death. |
| Secondary | Time to Definitive FACT-G Subscore Deterioration | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥3 points in a FACT-G subscore compared with baseline, with no subsequent improvement or deterioration \<3 points until the end of the study, or in a participant who drops out after a ≥3-point decrease resulting in missing data or death. |
| Secondary | Evolution of FACIT-Fatigue and FACT-G Scores and Subscores | Baseline through study completion, up to 3 years | Evolution of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score and subscores and the Functional Assessment of Cancer Therapy-General (FACT-G) total score and domain scores during the study, including assessments before and after surgery. The FACIT-Fatigue total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The FACT-G total score ranges from 0 to 108, with higher scores indicating better quality of life. |
| Secondary | Incidence of Adverse Events | During treatment through 28 days after the last dose | Incidence of adverse events graded according to NCI-CTCAE v5.0, including all AEs, grade ≥3 toxicities, treatment-related AEs, grade ≥3 neutropenia, SAEs, grade ≥3 hematological toxicities, related SAEs, and adverse device effects. |
| Secondary | Pathological Complete Response | At surgery | Pathological complete response (pCR) assessed at surgery. |
| Secondary | Net Treatment Benefit | From baseline through surgery following completion of neoadjuvant treatment, assessed up to approximately 30 weeks. | Net treatment benefit assessed using generalized pairwise comparisons based on prioritized outcomes: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score (range 0 to 52, with higher scores indicating less fatigue and better functioning), Functional Assessment of Cancer Therapy-General (FACT-G) total score (range 0 to 108, with higher scores indicating better quality of life), grade ≥3 neutropenia, and pathological complete response. |
| Secondary | Change From Baseline in Body Weight | Baseline through study completion, up to 3 years | Absolute change from baseline in body weight, measured in kilograms (kg), during the study, including changes during and between Fasten Onco active fasting-mimicking diet days. |
| Secondary | Event-Free Survival | From randomization through study completion, up to 3 years | Time from randomization to the first occurrence of disease relapse or death from any cause. |
| Secondary | Overall Survival | From randomization through study completion, up to 3 years | Time from randomization to death from any cause. |
| Secondary | Change From Baseline in FACT-Cog Score and Subscores | Baseline to end of neoadjuvant phase and 12 months after end of neoadjuvant phase | Absolute change from baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3, total score and subscale scores. The FACT-Cog assesses four domains: Perceived Cognitive Impairments, Impact of Perceived Cognitive Impairments on Quality of Life, Comments from Others, and Perceived Cognitive Abilities. Using the recommended 33-item scoring algorithm, the total score ranges from 0 to 132, with higher scores indicating better perceived cognitive functioning. |
| Secondary | Unscheduled Medical Events | From randomization through study completion, up to 3 years | Number of days of unscheduled hospitalization, number of unscheduled hospitalizations, and number of emergency consultations. |
| Secondary | Duration of Neoadjuvant Treatment Exposure | From first administration of Cycle 1 through last administration of Cycle 8; cycles are generally scheduled every 3 weeks | Duration in days from the first administration to the last administration of neoadjuvant treatment. |
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.
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