The effect of dexamethasone on symptom burden in patients with advanced cancer.
Bibliographic record
Abstract
TPS318 Background: Patients with advanced cancer experience severe physical and psychosocial symptoms (fatigue, pain, anorexia, and nausea) and this symptom burden reduces quality of life. The symptom expression is a multidimensional construct that results from different mechanisms of production and brain perception. Circulating cytokines (IL-6, IL-1b, TNF-alpha, IL-10, and IL-8) have been associated with fatigue, pain, anorexia, and nausea. There are limited treatment options to manage the overall symptom burden. Corticosteroids such as dexamethasone have been widely used in the treatment of fatigue, pain, anorexia, and nausea. But to date there are no well-powered placebo-controlled trials to draw definitive conclusions with regard to efficacy in management of these symptoms. In addition, not all assessment tools used were validated and there was no attempt to understand the pathophysiology using laboratory correlates. The objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of dexamethasone versus placebo to study its effect on cancer-related symptom burden and the association of dexamethasone in reducing the inflammatory cytokine levels and thereby symptom burden using validated tools and laboratory correlates. Methods: Advanced cancer patients with fatigue, pain, nausea, or anorexia greater than ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS), normal cognition, no infections and hemoglobin ≥ 9 g are eligible for enrollment. 125 eligible patients are randomized to dexamethasone 4 mg orally two times a day for 14 days (primary end point) or matching placebo. On day 15, all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone is tapered to 2 mg orally twice a day between days 22 to 28. All patients are off study on day 29. During the study period, patients will be assessed for the intensity of fatigue, pain, anorexia and nausea and other symptoms and toxicities. Patients undergo serial weekly assessments such as FACIT-F, cytokine levels (IL-1, IL-6, TNF- alpha,IL-10, IL-8, activated monocytes) and CRP levels. Current enrollment: To date 59 eligible patients with advanced cancer are enrolled. 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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
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".