Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2014
Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.
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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
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.International journal of oral science · 2025Guideline
- 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
- Protocols for management of oral complications of chemotherapy and/or radiotherapy for oral cancer: Systematic review and meta-analysis current.Medicina oral, patologia oral y cirugia bucal · 2017Pooled it
- Effects of an oral mucosa protective formulation on chemotherapy- and/or radiotherapy-induced oral mucositis: a prospective study.BMC cancer · 2022Trial
- 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 barrier-forming gel for oral mucositis in head and neck cancers patients undergoing radiotherapy: randomized, controlled, multicenter trial.EClinicalMedicine · 2025Article
- Barrier-forming lipid solution for severe oral mucositis: effect on oral intake interruption in head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Article
- Addressing Pain in Oral Mucositis: Narrative Review of Current Practices and Emerging Treatments.Journal of pain research · 2025Review
- Formulation and Evaluation of Triamcinolone Acetonide-Loaded Oral Disintegrated Film with Different PolymersTurkish journal of pharmaceutical sciences · 2024Article
- Efficacy of Episil® in patients with hematologic malignancies: a comparative study.BMC oral health · 2024Article
- Ayurvedic Drug Triphala in Combination with Providone Iodine Mitigates Radiation-Induced Mucositis in Head and Neck Cancer Patients without Affecting the Tumor Response.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2023Article
- Evaluation of the topical gel and oral administration of Punica Granatum Var Pleniflora on oral mucositis induced by 5-Fluorouracil in golden hamsters.BMC complementary medicine and therapies · 2023Article
- Clinical investigation of use of Episil® oral solution in oral mucositis during radiotherapy for head and neck cancer.Heliyon · 2023Article
- Status of Treatment and Prophylaxis for Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer.Frontiers in oncology · 2021Review
- Effects of a bioadhesive barrier-forming oral liquid on pain due to radiation-induced oral mucositis in patients with head and neck cancer: A randomized crossover, preliminary study.Journal of dental sciences · 2021Article
- A Bioadhesive Barrier-Forming Oral Liquid Gel Improved Oral Mucositis and Nutritional Status in Patients With Head and Neck Cancers Undergoing Radiotherapy: A Retrospective Single Center Study.Frontiers in oncology · 2021Article
- Oral Management of a Haematopoietic Stem Cell Transplant Recipient with Chédiak-Higashi Syndrome.Case reports in dentistry · 2021Article
- Ibuprofen gargle for chemo- or Chemoradiotherapy-induced Oral Mucositis: a feasibility study.Journal of pharmaceutical health care and sciences · 2020Article
- Effects of a compound vitamin B mixture in combination with GeneTime® on radiation-induced oral mucositis.The Journal of international medical research · 2019Observational
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCAM2028, a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa, was developed as a carrier system for local delivery of benzydamine, an NSAID used for pain relief in oral mucositis. This trial compared the analgesic effect of CAM2028 plus benzydamine (CAM2028-benzydamine) with unmedicated CAM2028 (CAM2028-control) for the treatment of oral mucositis in patients with head-and-neck cancer.
methodsThirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy. Participants were required to have symptomatic oral mucositis (WHO Grade 2 or above) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication. After undergoing radiation, patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart, in a randomized crossover fashion. Pain was assessed over the following 8 h.
resultsWith both treatments, patients experienced a mean 40 % decrease in pain intensity at 6 h (the primary study endpoint). Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period. There was no difference in pain relief between the two interventions at any time point. Both treatments were safe and well tolerated.
conclusionsCAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer. Analgesic effects of both medications were immediate, clinically significant, and persistent for up to 8 h.
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