Efficacy and Safety of Nuvastatic™ in Improving Cancer-related Fatigue: A Phase II Multicenter Randomized Controlled Trial
Bibliographic record
Abstract
Abstract Puropse We evaluated the efficacy and safety of Nuvastatic™ in improving cancer-related fatigue (CRF) among cancer patients. Methods This multicenter randomized double-blind placebo-controlled phase-2 trial included 110 solid malignant tumor patients (stage I–IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory [BFI]) and Visual Analog Scale for Fatigue [VAS-F]) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration, Eastern Cooperative Oncology Group scores, and biochemical and hematologic parameters. Clinical outcomes were assessed using two-way repeated-measures analysis of variance on intention-to-treat population. Results The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. The BFI estimated mean difference (eMD) was 15.29 (95% CI: 12.77–17.82) and VAS-F eMD was 11.19 (95% CI: 8.06–14.32) were significantly different between two groups at week 9 (p < 0.001). The overall treatment effect was significant for BFI (p < 0.001) and VAS-F (p < 0.001). Within group assessment showed significant fatigue improvement in both the groups (p < 0.001). Quality of life was significantly improved in the Nuvastatic™ group with eMD of 70.81, (95% CI: 58.34–83.28; p < 0.001) SF-36 scores. Additionally, F2-isoprostane concentrations significantly decreased in the Nuvastatic™ group (p = 0.006). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%). Conclusion Nuvastatic™ is an effective adjuvant for CRF in solid tumor patients.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".