Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Preliminary Placebo-Controlled, Randomized, Double-Blind Trial
Bibliographic record
Abstract
BACKGROUND: Physical activity (PA) and dexamethasone (Dex) when used independently have modest benefits for cancer-related fatigue (CRF) in patients with advanced cancer. In this study we aimed to determine the feasibility (adherence, safety, and satisfaction) of combining PA with Dex versus PA with placebo (PBO) for CRF, and to explore the effects of PA+Dex and PA+PBO on CRF. PATIENTS AND METHODS: In this phase II, randomized, double-blind controlled trial, eligible patients had advanced cancer and a CRF score of ≥4 on the Edmonton Symptom Assessment Scale (ESAS) for fatigue (0-10 scale). Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (PA+Dex arm) or PBO (PA+PBO arm) twice daily for the first 7 days. Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores from baseline to days 8 and 29 were assessed. Other outcomes included change in quality-of-life scores. RESULTS: A total of 64 (89%) patients were evaluable. Adherence rates for study medication, resistance exercise, and aerobic exercise were 91% and 92% (P=.15), 83% and 70.6% (P=.35), and 82.9% and 78.3% (P=.73), respectively, in the PA+Dex and PA+PBO arms. The satisfaction rates for the PA+Dex and PA+PBO arms were 98% and 79%, respectively. Median (IQR) changes in FACIT-F scores at days 8 and 29 from baseline were 9 (2 to 16; P<.001) and 5.75 (0 to 12.5; P=.015) for the PA+Dex arm, respectively, and 3.5 (-2.1 to 10; P=.054) and 6.5 (2.5 to 15.5; P=.006) for the PA+PBO arm, respectively. We found a significant treatment effect in the PA+Dex arm using exploratory linear mixed model analysis, with treatment showing an improvement of 5.63 units for FACIT-F scores (95% CI, 1.74-9.52; P=.005). We found significant improvement in Functional Assessment of Cancer Therapy-General (FACT-G), Patient-Reported Outcomes Measurement Information System-Fatigue Short Form 7a (PROMIS-Fatigue SF-7a), and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) totals on days 8 and 29 in the PA+Dex arm. There was no significant difference in grade ≥3 adverse events between the arms (P=.36). CONCLUSIONS: Our study found that the use of combination PA+Dex and PA+PBO for CRF was feasible and associated with high rates of satisfaction, adherence to medication and PA intervention, and tolerability. CRF improvement with PA+Dex was clinically significant at days 8 and 29. Further larger studies are justified. CLINICALTRIALS: gov identifier: NCT03583255.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| 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".