Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Doxepin rinse versus placebo in the treatment of acute oral mucositis pain in patients receiving head and neck radiotherapy with or without chemotherapy: a phase III, randomized, double-blind trial (NCCTG-N09C6 [Alliance]).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.
- Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.International journal of oral science · 2025Guideline
- Topical Treatment of Oral Mucositis in Cancer Patients: A Systematic Review of Randomized Clinical Trials.Asian Pacific journal of cancer prevention : APJCP · 2020Pooled it
- Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics 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 · 2020Pooled it
- Effects of topically applied liquid N-acetylcysteine for the management of burning mouth syndrome.Scientific reports · 2025Trial
- Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Trial
- Phase 1b/2a Trial of the Superoxide Dismutase Mimetic GC4419 to Reduce Chemoradiotherapy-Induced Oral Mucositis in Patients With Oral Cavity or Oropharyngeal Carcinoma.International journal of radiation oncology, biology, physics · 2018Trial
- Treatment of severe mucositis pain with oral ketamine mouthwash.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Trial
- A meta-analysis of pain intensity changes after placebo interventions in facial pain.Pain reports · 2026Review
- Effectiveness and Tolerability of Topical Amitriptyline 10% Plus Lidocaine 2% Gel in Adults With Post-Traumatic Trigeminal Neuropathic Pain: A Real-World Evidence Study.Journal of oral rehabilitation · 2026Observational
- Article
- Addressing Pain in Oral Mucositis: Narrative Review of Current Practices and Emerging Treatments.Journal of pain research · 2025Review
- A double layer oral film loaded with doxepin hydrochloride for the treatment of chemotherapy-induced oral mucositis.Frontiers in pharmacology · 2025Article
- Article
- Assessment of thyme honey oral gel for the prevention of adriamycin and cyclophosphamide chemotherapy-induced oral mucositis in patients with breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Article
- Efficacy, safety, and tolerability of antidepressants for pain in adults: overview of systematic reviews.BMJ (Clinical research ed.) · 2023Review
- J-SUPPORT research policy for oral mucositis associated with cancer treatment.Cancer medicine · 2022Article
- [Management of chemotherapy side effects and their long-term sequelae].Der Urologe. Ausg. A · 2021Review
- Topical Treatments and Their Molecular/Cellular Mechanisms in Patients with Peripheral Neuropathic Pain-Narrative Review.Pharmaceutics · 2021Review
- Radiotherapy-Specific Chronic Pain Syndromes in the Cancer Population: An Evidence-Based Narrative Review.Advances in therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
purposePainful oral mucositis (OM) is a significant toxicity during radiotherapy for head and neck cancers. The aim of this randomized, double-blind, placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain. PATIENTS AND
methodsIn all, 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain. Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day. Pain questionnaires were administered at baseline and at 5, 15, 30, 60, 120, and 240 minutes. Patients were then given the option to continue doxepin. The primary end point was pain reduction as measured by the area under the curve (AUC) of the pain scale using data from day 1.
resultsPrimary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin (-9.1) than for placebo (-4.7; P < .001). Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin (intrapatient changes of 4.1 for doxepin-placebo arm and -2.8 for placebo-doxepin arm; P < .001). Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse. More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study.
conclusionA doxepin rinse diminishes OM pain. Further studies are warranted to determine its role in the management of OM.
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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.