Phase III trial of antioxidant vitamins to prevent acute side effects of radiation therapy in head and neck cancer (HNC) patients
Bibliographic record
Abstract
3017 Background: Many cancer patients take antioxidant vitamins in the hope of improving the outcome of therapies and of reducing treatments side effects. We conducted a randomized trial to determine whether a supplementation with antioxidant vitamins could reduce the occurrence and severity of acute side effects of radiation therapy (ASERT) and improve quality of life without compromising treatment efficacy (second objective of the trial). Methods: This randomized, double-blind, placebo-controlled trial was conducted among 540 stage I or II HNC patients treated by radiation therapy. The supplementation with alpha tocopherol (400 IU/day) and beta carotene (30 mg/day) or placebos was given during radiation therapy and for 3 years thereafter. From October, 1994 to June, 2000, 273 and 267 patients were randomized in the supplement and the placebo arms, respectively. This study population provided 91% power to detect a 50% reduction in the frequency of grade 3 and 4 ASERT in the supplement arm with two-sided α=0.05. In 1996, beta carotene was discontinued after recommendation of the trial’s ethical and safety monitoring committee. Ordinal logistic regression was used to estimate the cumulative odds ratios (OR) associated with ASERT one grade higher, with their 95% confidence intervals (CI). Cox proportional hazard model was used to estimate the hazard ratio of local recurrence. No interim analysis was conducted. Results: Patients in the supplement arm had less severe ASERT during radiation therapy (OR=0.72, 95% CI: 0.52–1.02). The reduction was statistically significant when the supplementation combined alpha tocopherol and beta carotene (OR=0.38, 95% CI: 0.20–0.74). Overall, quality of life was not improved by the supplementation. The rate of local recurrence of the HNC tended to be higher in the supplement arm: HR=1.37, 95% CI: 0.93- 2.02. Conclusions: Supplementation with high doses of alpha tocopherol and beta carotene during radiation therapy could reduce the severity of ASERT. However, high doses of antioxidants as adjuvant therapy might compromise radiation treatment efficacy. No significant financial relationships to disclose.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| 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".