A Randomized Crossover Clinical Trial to Evaluate the Efficacy of Oral Transmucosal Fentanyl Citrate in the Treatment of Dyspnea on Exertion in Patients With Advanced Cancer
Bibliographic record
Abstract
BACKGROUND: Morphine is the only opioid which has been clearly demonstrated as effective in the treatment of dyspnea. The role of other opioids has not been sufficiently substantiated. OBJECTIVE: To evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of dyspnea on exertion in patients with advanced cancer. DESIGN: This is a randomized, double-blind crossover clinical trial to evaluate the efficacy of OTFC in dyspnea on exertion after the completion of a 6-minute walk test (6MWT). All patients were attended in 2011 by the Palliative Care Supportive Team from Badajoz. In visit 1, patients were randomly assigned to 1 of the 2 treatment groups. In visit 2, the patients who had been receiving the investigational product were given placebos and vice versa. RESULTS: Thirteen patients were recruited (26 6MWT), with a mean age of 65 years. Of the patients, 11 (76%)were males and lung cancer was the most frequently represented etiology. The patients were classified into 3e categories: better response in the first period, the same response in both the periods, and better response in the second period. No differences between the treatments were demonstrated (P: 1). There were no differences in changes in oxygen saturation (P: .7541) nor in the distance walked in the different sequences (P: .6550). No significant differences were found in relation to the Edmonton Symptom Assessment System, either before or after the 6MWT (P: .1234). No secondary effects associated with the medication were observed. CONCLUSION: It could not be demonstrated that the OTFC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all the patients.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".