Parenteral hydration (PH) in advanced cancer patients: A multi-center, double-blind, placebo-controlled randomized trial.
Bibliographic record
Abstract
9025 Background: The vast majority of cancer patients at the end of life receive PH in hospitals and no PH in hospice. There is limited evidence supporting either practice. Our preliminary study suggested that PH (1L/day) improved dehydration symptoms (Bruera et al. JCO 2005). In this randomized controlled trial, we determined the effect of PH on symptoms associated with dehydration, quality of life and survival for patients with advanced cancer. Methods: We randomly assigned 129 cancer patients from 6 hospices to receive subcutaneous PH (normal saline 1 L/day) or placebo (normal saline 100 mL/day) daily over 4 hours. The primary outcome was change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations, 0=best and 40=worst possible) between day 4 and baseline. Secondary outcomes included Edmonton Symptom Assessment Scale (ESAS), Memorial delirium assessment scale [MDAS], Nursing delirium screening scale [NuDESC], unified myoclonus rating scale [UMRS], FACIT-F, creatinine, urea, and overall survival. Intention-to-treat analysis was conducted to examine the change in each variable between baseline and day 4 or day 7. Log rank test was used for survival analysis. Results: Mean age was 67 (range 43-92), female 61%, Caucasians 60%, gastrointestinal, genitourinary and lung cancers 70%, performance status 3-4 113 (88%), with no baseline differences between the hydration (N=63) and placebo (N=66) groups. No significant differences were found between the hydration and placebo groups for the sum of 4 dehydration symptoms (-3.3 v. -2.8, p=0.77), ESAS (all non-significant), MDAS (1 vs. 3.5, p=0.084), NuDESC (0 v. 0, p=0.13) and UMRS (0 vs. 0, p=0.54). We also did not identify any group differences for day 7, except for a decrease in urea level in the hydration group (-2 vs. 2, P=0.02). Median overall survival was 21 days for PH and 15 days for placebo (p=0.83). Conclusions: PH at 1 L/day did not improve symptoms, quality of life or survival compared to placebo. Further studies are required to determine if any subgroups would benefit from PH.
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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) | 0.002 | 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 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".