Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2017
Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (>50 Gy) with or without chemotherapy.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 6 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
30 citing papers in PubMed, 6 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.International journal of oral science · 2025Guideline
- Anti-inflammatory mouthwashes for the prevention of oral mucositis in cancer therapy: an integrative review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Pooled it
- A systematic review of interventions to mitigate radiotherapy-induced oral mucositis in head and neck cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Pooled it
- 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 · 2019Pooled it
- The effectiveness of mouthwashes in alleviating radiation-induced oral mucositis in head and neck cancer patients: a systematic review.Oral radiology · 2019Pooled it
- Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis.Medicina (Kaunas, Lithuania) · 2019Pooled it
- The role of compounded mouthwash with or without acyclovir in managing chemotherapy-induced oral mucositis in cancer patients: a randomized controlled trial.BMC oral health · 2025Trial
- Rebamipide gargle and benzydamine gargle in prevention and management of chemo-radiotherapy and radiotherapy-induced oral mucositis in head and neck cancer patients (randomized clinical trial).BMC oral health · 2024Trial
- Potential therapeutic effects of different mouthwashes for alleviation and treatment of oral complications of 5-fluorouracil-based chemotherapy in patients with colon cancer.European journal of hospital pharmacy : science and practice · 2023Trial
- Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer.Oral health & preventive dentistry · 2020Trial
- Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Trial
- Radiation-induced oral side effects in head and neck cancer: a scoping review and interdisciplinary recommendations.BMC oral health · 2026Article
- Painful Realities: Navigating the Complexities of Head and Neck Cancer Pain.Oral diseases · 2025Review
- The effect of different mouthwashes to prevent oral mucositis in patients with radiotherapy and chemotherapy: a network meta-analysis.BMC complementary medicine and therapies · 2025Article
- Oral Management of Patients Undergoing Head and Neck Cancer Treatment.Journal of maxillofacial and oral surgery · 2024Review
- Dentist Involvement in the Treatment of Radiation-Induced Oral Mucositis-A Pilot Cross-Sectional Study.Dentistry journal · 2024Article
- Benzydamine hydrochloride: an overview on a well-established drug with news in mechanisms of action.F1000Research · 2024Review
- Management of radiation-induced oral mucositis in head and neck cancer patients: a real-life survey among 25 Italian radiation oncology centers.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Review
- Review Article a Multidisciplinary Evaluation for Advanced Supportive Care of Breast Cancer Patients.Breast care (Basel, Switzerland) · 2023Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeBenzydamine is recommended for prophylaxis of oral mucositis (OM) in head and neck cancer (HNC) patients for radiation doses (<50 Gy). This study evaluates role of benzydamine for higher radiation doses (>50 Gy) with or without chemotherapy.
methodsOne hundred twenty patients of HNC with planned radiation doses of ≥60 Gy were randomized to group A (control radiotherapy alone), group B (study radiotherapy alone), group C (control chemoradiotherapy), or to group D (study chemoradiotherapy). Groups A and C were advised saline mouth rinses, and in groups B and D, additional benzydamine rinses (0.15%) were advised. Mucositis grading was done with both WHO (WHO-M) and CTCAE (CTC-M) version 4.0 (common terminology criteria for adverse events) weekly.
resultsPatient characteristics are presented in the table. Patients in group B had lesser grade 3 WHO-M and CTC-M as compared to group A, 62.1 vs. 36.4% (p = 0.038) and 51.7 vs. 27.3% (p = 0.043), respectively. The rates of Ryle's tube feeding (RTF), intravenous fluid supplementation (IVF), and hospitalization were also lesser in group B as compared to A, 34.5 vs. 21.2% (p = 0.18), 27.6 vs. 9.1% (p = 0.06), and 6.9 vs. 0% (p = 0.21), respectively. WHO-M and CTC-M in groups C and D were not statistically different, 64.3 vs. 43.3% (p = 0.091) and 53.6% vs. 43.3% (p = 0.30), respectively. The rates of RTF, IVF, and hospitalization were all lesser but p > 0.05.
conclusionBenzydamine significantly reduces OM even at doses >50 Gy in HNC patients. Its role in patients receiving concurrent chemotherapy further needs to be evaluated.
Indexed as
Identifiers
What OpenQuestion holds
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.