Alleviating breathlessness in patients with cancer with dexamethasone (ABCD): A parallel-group, double-blind, randomized clinical trial (RCT).
Notice bibliographique
Résumé
12112 Background: Systemic corticosteroids are commonly prescribed for palliation of dyspnea in patients with cancer; however, evidence to support their use is limited. A small RCT suggested that dexamethasone may be efficacious. In this confirmatory RCT, we compared the effect of high dose dexamethasone and placebo on dyspnea in patients with cancer. Methods: This NCI-funded, multi-site, double-blind, parallel group RCT enrolled ambulatory patients with cancer, age ≥18, dyspnea ≥4/10 and randomly assigned them to receive dexamethasone 8 mg orally every 12 hours for 7 days followed by 4 mg orally every 12 hours for 7 days or matching placebo capsules. Permuted block randomization (block size = 6, 2:1) was conducted, stratified by baseline dyspnea and study site. Patients, research staff and clinicians were blinded. The primary outcome was change in average dyspnea intensity assessed with a 0-10 numeric rating scale (0 = none, 10 = worst) between baseline and day 7. Secondary outcomes included the Edmonton Symptom Assessment Scale (ESAS) and adverse effects (CTCAE v4.02). Intention-to-treat analysis was conducted with linear models to compare between groups. The planned sample size of 201 patients provided 80% power to detect a mean difference of 1.0 between treatment groups with a two-sided α of 5%, assuming a standard deviation of 2.0 and 15% attrition. (Clinicaltrials.gov NCT03367156). Results: Between 1/11/2017 and 4/23/2021, we enrolled 149 patients and 128 received the blinded study interventions (dexamethasone n = 85, placebo n = 43). Enrollment was terminated early by the Data Safety Monitoring Board when futility criterion was met in pre-planned interim analysis. The mean change in dyspnea NRS intensity between baseline and day 7 was -1.6 (95% CI -2, -1.2) in the dexamethasone group and -1.6 (95% CI -2.3, -0.9) in the placebo group, with no significant between-group difference (mean 0, 95% CI -0.8, 0.7; P = 0.91). Secondary analyses showed that the dexamethasone group had a significantly better ESAS appetite (mean difference -1.2, 95% CI -2.2, -0.1; P = 0.03) and well being (mean -1, 95% CI -1.8, -0.2; P = 0.02), and worse ESAS anxiety (mean 1.1, 95% CI 0.3, 1.9; P = 0.01) and depression (mean 0.9, 95% CI 0.1, 1.7; P = 0.02) compared to placebo. Similar magnitude of changes in dyspnea and ESAS symptoms were observed by day 14. Adverse effects were reported more frequently in the dexamethasone group (any grade): insomnia (38% v. 12%), neuropsychiatric symptoms (31% vs. 7%), infections (21% v. 12%), dyspepsia (26% v. 12%), edema (18% v. 9%), hiccups (12% v. 7%), flushing (9% v. 5%) and respiratory distress (6% v. 0%). More patients in the dexamethasone group required hospitalization within 30 d of last study medication (25% vs. 7%, P = 0.02). Conclusions: High dose dexamethasone did not improve dyspnea in patients with cancer more than placebo and was associated with more adverse events. Clinical trial information: NCT03367156.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,009 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,005 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,004 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,013 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».