Evidence map›Paper›PMID 25151488›Full record

Trial reportOral oncology2014

Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis in patients receiving radiation therapy for head and neck cancer.

Rajesh V Lalla, Linda E Choquette, Kathleen F Curley, Robert J Dowsett, Richard S Feinn, Upendra P Hegde, Carol C Pilbeam, Andrew L Salner, Stephen T Sonis, Douglas E Peterson

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Oral oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00698204 (Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00698204 phase2completednot on this map

Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

TypeinterventionalSponsorUConn HealthRan2003 to 2013Enrolled43ConditionsOral MucositisArmscelecoxib, placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Pooled it
  4. Trial
  5. Therapeutic targeting of COX-2 in head and neck cancer: Mechanistic and clinical perspectives.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
    Review
  6. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  7. Article
  8. Review
  9. Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
  10. Article
  11. Review
  12. Article
  13. Is pain part of a systemic syndrome in head and neck cancer?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Review
  14. The pathogenesis of mucositis: updated perspectives and emerging targets.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Review
  15. Text mining-based in silico drug discovery in oral mucositis caused by high-dose cancer therapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Article
  16. Intra-oral administration of rebamipide liquid prevents tongue injuries induced by X-ray irradiation in rats.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Article
  17. Modulation of radiation-induced oral mucositis by thalidomide : Preclinical studies.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Article
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Rajesh V LallaUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA. Electronic address: Lalla@uchc.edu.
Linda E ChoquetteUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
Kathleen F CurleyUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
Robert J DowsettUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
Richard S FeinnFrank Netter MD School of Medicine at Quinnipiac University, 275 Mount Carmel Avenue, Hamden, CT 06518, USA.
Upendra P HegdeUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
Carol C PilbeamUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
Andrew L SalnerHartford Hospital, 80 Seymour Street, Hartford, CT 06102, USA.
Stephen T SonisBrigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
Douglas E PetersonUniversity of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT 06030, USA.
UConn Health · USBrigham and Women's Hospital · USHartford Hospital · USQuinnipiac University · US

Funding

ZONISAMIDE VERSUS PLACEBOM01RR006192 · NCRR · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI DRAZINIC, CAROLYN M · 1994 to 2008
$22.1M
Cox-2 Regulation of Bone Responses to PTH: Role of OsteoclastsR01AR060286 · NIAMS · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI PILBEAM, CAROL C. · 2011 to 2020
$3.4M
COX-2 Inhibition in Radiation-induced Oral MucositisK23DE016946 · NIDCR · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI LALLA, RAJESH V. · 2005 to 2009
$692k
NCRR NIH HHS M01 RR006192NCRR NIH HHS M01RR06192NIDCR NIH HHS K23 DE016946NIDCR NIH HHS K23DE016946
6 · The paper itself

Abstract

objectivesOral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck cancer (H&NC). OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Based on the role of inflammatory pathways in OM pathogenesis, we investigated effect of cyclooxygenase-2 (COX-2) inhibition on severity and morbidity of OM.

methodsIn this double-blind placebo-controlled trial, 40 H&NC patients were randomized to daily use of 200 mg celecoxib or placebo, for the duration of RT. Clinical OM, normalcy of diet, pain scores, and analgesic use were assessed 2-3 times/week by blinded investigators during the 6-7 week RT period, using validated scales.

resultsTwenty subjects were randomized to each arm, which were similar with respect to tumor location, radiation dose, and concomitant chemotherapy. In both arms, mucositis and pain scores increased over course of RT. Intention-to-treat analyses demonstrated no significant difference in mean Oral Mucositis Assessment Scale (OMAS) scores at 5000 cGy (primary endpoint). There was also no difference between the two arms in mean OMAS scores over the period of RT, mean worst pain scores, mean normalcy of diet scores, or mean daily opioid medication use in IV morphine equivalents. There were no adverse events attributed to celecoxib use.

conclusionsDaily use of a selective COX-2 inhibitor, during period of RT for H&NC, did not reduce the severity of clinical OM, pain, dietary compromise or use of opioid analgesics. These findings also have implications for celecoxib use in H&NC treatment regimens (NCT00698204).

Indexed as

AdultAgedCelecoxibDouble-Blind MethodFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedPlacebosPyrazolesRadiotherapyStomatitisSulfonamidesCelecoxibPlacebosPyrazolesSulfonamidesCelecoxibCyclooxygenaseHead and neck cancerOral mucositisRadiation therapyStomatitis

Identifiers

PMID25151488
PMCPMC4856470
OpenAlexW1997939979

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.