PRO-ACTIVE: Results of a pragmatic phase IV randomized trial comparing the effectiveness of prophylactic swallow intervention for patients receiving radiotherapy for head and neck cancer.
Bibliographic record
Abstract
LBA12000 Background: Swallowing therapy during radiotherapy (RT) for head and neck cancer (HNC) has gained popularity as a dysphagia mitigation strategy, yet optimal timing and intensity of therapy remains uncertain. The PRO-ACTIVE trial compared the effectiveness of prophylactic and reactive swallowing therapies during RT. We hypothesized that PRO-ACTIVE therapies are more effective than RE-ACTIVE; and, that more intensive PRO-ACTIVE (EAT+EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Methods: PRO-ACTIVE was an international, multi-site pragmatic phase IV randomized clinical trial (NCT03455608). Eligible, adult patients had functional baseline swallowing and received RT ≥60-Gy for HNC with bilateral neck fields. Prior to RT, patients were randomized 1:2:2 to 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, or 3) PRO-ACTIVE EAT+EXERCISE arms and followed for 1 year. RE-ACTIVE received weekly monitoring with therapy only if/when dysphagic, and PRO-ACTIVE arms received bi-weekly therapy pre- and during RT. The primary endpoint was feeding tube (FT) use in days from the end of RT to 1 year. Secondary endpoints were patient-reported and clinician-graded outcomes. Adjusted linear regression compared FT days per intention-to-treat with a gate-keeper approach to test hypotheses in hierarchical order with 80% power to detect a small effect size (≥.21 SD) with type 1 error probability of 0.5 (two-sided). Results: 952 patients from 13 institutions were randomized to RE-ACTIVE (n=196), PRO-ACTIVE-EAT (n=377) or PRO-ACTIVE-EAT+EXERCISE (n=379). 21 (2.2%) patients exited before intervention, thus, 931 were retained for analysis. The majority had stage I/II disease (552/931, 59.3%), oropharyngeal tumors (647/931, 69.5%), and p16+ and/or HPV+ disease (680/931, 73.0%). Baseline function was excellent (499/931 (53.5%) grade 0 dysphagia, mean [SD] MDADI 86 [14]). All patients received curative intent RT (median 70 Gy), 706/931 (75.8%) with chemotherapy, and 105/931 (11.3%) with primary site surgery. 364 of 931 (39.1%) required a FT with 34.4 (SD 75.9) mean days of use. Adjusted FT days at 12-months did not meaningfully differ by pro- and re-active timing (∆5.4 days, 95% CI -6.5 to 17.2, p=0.37) or EAT versus EAT+exercise intensity (∆5.9 days, 95% CI -3.8 to 17.6, p=0.21). Swallowing-related QOL, diet, weight/BMI, and dysphagia symptoms did not differ meaningfully by arm. Conclusion: FT utilization was lower than expected and secondary measures of swallowing outcomes were favorable across all arms of the PRO-ACTIVE trial reflecting relative effectiveness of EAT and exercise therapies regardless of timing or intensity of therapy delivery during RT for HNC. As a pragmatic trial, we are robustly powered to examine heterogeneous treatment effects in subgroup analyses and image-based swallowing metrics as critical next steps. Clinical trial information: NCT03455608 .
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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 | 0.022 | 0.016 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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".