Olanzapine for Anorexia in Patients With Incurable Cancer and Cachexia (OlAnCa): A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Bibliographic record
Abstract
BACKGROUND: Pharmacologic options for managing anorexia in cancer cachexia are limited. This trial aimed to evaluate the efficacy of olanzapine in alleviating anorexia in patients with incurable cancer and cachexia. METHODS: This double-blind, placebo-controlled, randomized trial included adult patients with incurable cancer and cachexia, scoring ≥4 on the Edmonton Symptom Assessment Scale (ESAS) anorexia item (ESAS-Anorexia) and <4 on the ESAS nausea item (ESAS-Nausea). A total of 164 patients were randomized in a 1:1 ratio to receive either placebo (n=82) or olanzapine 5 mg daily (n=82) for 4 weeks. The primary outcome was the change in ESAS-Anorexia score after 1 week. Secondary outcomes included changes in anorexia and quality of life scores, body weight, and handgrip strength after 4 weeks. RESULTS: In the complete case analysis of the primary outcome (n=159; 97%), median [IQR] reduction in ESAS-Anorexia score after 1 week was significantly greater in the olanzapine group (-2 [-3 to 0] vs -1 [-2 to 0]; P=.003). The significance continued at 2 weeks (-2 [-4 to -1] vs -1 [-2 to 0]; P=.039). After 4 weeks, significantly more patients in the olanzapine group experienced >5% weight gain (14% vs 0%; P=.008), and the mean [SD] improvement in Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale score was higher (+2.7 [7.4] vs -0.04 [7]; P=.043). The mean [SD] decline in handgrip strength was greater with olanzapine and was significant in per-protocol analysis (-2.8 [4.9] kg vs -0.3 [4.1] kg; P=.027). Anxiety, insomnia, and nausea (P=.016, P=.034, and P=.039, respectively) were significantly less frequent with olanzapine, whereas grade ≥3 anemia and leukopenia were more frequent (P=.018 and P=.041, respectively). CONCLUSIONS: A short course of olanzapine 5 mg daily significantly reduces anorexia in patients with incurable cancer and cachexia. Further studies are needed to evaluate its long-term safety and efficacy in cancer cachexia.
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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) | 0.008 | 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".