Trial reportCancer2014
Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck.
Trial report in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 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.
Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT: A Single-center, Randomized Controlled Trial
Single-Dose Pharmacokinetics of Atropine Oral Gel in Healthy Adults
Who cites it
25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- 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
- The effectiveness of mouthwashes in alleviating radiation-induced oral mucositis in head and neck cancer patients: a systematic review.Oral radiology · 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
- 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
- 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
- Bioactive Hydrogels and Scaffolds for Oral Mucosal Regeneration After Oral Squamous Cell Carcinoma Therapy: A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2026Review
- Barrier Products for Topical Delivery-Insight into Efficacy Testing and Barrier-Boosting Compounds.Pharmaceutics · 2025Review
- Recombinant Human Keratinocyte Growth Factor Ameliorates Cancer Treatment-Induced Oral Mucositis on a Chip.Advanced healthcare materials · 2024Article
- Clinical pharmacokinetics of atropine oral gel formulation in healthy volunteers.Clinical and translational science · 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
- Localized Drug Delivery Systems: An Update on Treatment Options for Head and Neck Squamous Cell Carcinomas.Pharmaceutics · 2023Review
- Advanced biomedical hydrogels: molecular architecture and its impact on medical applications.Regenerative biomaterials · 2021Review
- Oral mucositis: the hidden side of cancer therapy.Journal of experimental & clinical cancer research : CR · 2020Review
- 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 · 2020Review
- Phase II randomized trial of a non-steroidal mouth wash for prevention and treatment of stomatitis in women with hormone receptor positive breast cancer treated with everolimus.Therapeutic advances in medical oncology · 2020Article
- Ibuprofen gargle for chemo- or Chemoradiotherapy-induced Oral Mucositis: a feasibility study.Journal of pharmaceutical health care and sciences · 2020Article
- Hydrogels Based Drug Delivery Synthesis, Characterization and Administration.Pharmaceutics · 2019Review
- Potential Therapeutic Effects of Gut Hormones, Ghrelin and Obestatin in Oral Mucositis.International journal of molecular sciences · 2019Review
- Hydrogels and Their Applications in Targeted Drug Delivery.Molecules (Basel, Switzerland) · 2019Review
- Utilizing Superoxide Dismutase Mimetics to Enhance Radiation Therapy Response While Protecting Normal Tissues.Seminars in radiation oncology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 16 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe objective of this trial was to determine how a mucoadhesive hydrogel (MuGard), a marketed medical device, would fare when tested with the strictness of a conventional multi-institutional, double-blind, randomized, placebo-controlled study format.
methodsA total of 120 subjects planned to receive chemoradiation therapy (CRT) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse (SC) during CRT. Subjects completed the validated Oral Mucositis Daily Questionnaire. Weight, opiate use, and World Health Organization (WHO) oral mucositis (OM) scores were recorded. Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis.
resultsOf 120 subjects enrolled, 78 (SC, N=41; MuGard, N=37) were eligible for efficacy analysis. Both cohorts were similar in demographics, baseline characteristics, primary tumor type, and planned CRT regimen. MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness (P=.034) and WHO scores on the last day of radiation therapy (P=.038). MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration, and OM scores (WHO criteria) at CRT week 4. Rinse compliance was identical between cohorts. No significant adverse events were reported, and the adverse event incidence was similar between cohorts.
conclusionsTesting MuGard, a rinse marketed as a device, in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms, delaying OM progression, and its safety and tolerability.
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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.