Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2021
Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.
Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
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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
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025Pooled it
- Pooled it
- Quality-of-life outcomes following topical melatonin application against acute radiation dermatitis in patients with early breast cancer: A double-blind, randomized, placebo-controlled trial.Journal of pineal research · 2023Trial
- Melatonin beyond chronobiology: integrating pharmacokinetics, dose-exposure forecasting, and clinical evidence.Molecular biology reports · 2026Review
- Radiotherapy and cytokines: A systems view of immunotherapy and toxicity (Review).International journal of molecular medicine · 2026Review
- Regimen-Related Oral Mucosal Injury: Pathobiology, Clinical Consequences and Rationale for Intervention Across Cancer Treatment Modalities.Current oncology reports · 2026Review
- Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026Review
- Therapeutic Potential of Melatonin in Gastrointestinal Cancers: Molecular Mechanisms, Preclinical Evidence and Clinical Implications.Journal of pineal research · 2026Review
- Unraveling the complexity of radiotherapy- and chemotherapy-induced oral mucositis: insights into pathogenesis and intervention strategies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Review
- Impact of clinical and dosimetric factors on severe oral mucositis in head and neck cancer: insights from a phase II clinical trial.Frontiers in oncology · 2025Article
- Melatonin in Chemo/Radiation Therapy; Implications for Normal Tissues Sparing and Tumor Suppression: An Updated Review.Current medicinal chemistry · 2025Review
- Evaluation of oral mucositis severity and management in head and neck cancer patients undergoing radiotherapy: A prospective study.Bioinformation · 2025Article
- Article
- The Metformin Immunoregulatory Actions in Tumor Suppression and Normal Tissues Protection.Current medicinal chemistry · 2024Review
- Management of Oral Hygiene in Head-Neck Cancer Patients Undergoing Oncological Surgery and Radiotherapy: A Systematic Review.Dentistry journal · 2023Review
- Potential of melatonin to reverse epigenetic aberrations in oral cancer: new findings.EXCLI journal · 2023Review
- J-SUPPORT research policy for oral mucositis associated with cancer treatment.Cancer medicine · 2022Article
- The Self-Administered Use of Complementary and Alternative Medicine (CAM) Supplements and Antioxidants in Cancer Therapy and the Critical Role of Nrf-2-A Systematic Review.Antioxidants (Basel, Switzerland) · 2022Review
- Noninvasive Systemic Modalities for Prevention of Head and Neck Radiation-Associated Soft Tissue Injury: A Narrative Review.Journal of reconstructive microsurgery · 2022Review
- Use of Melatonin in Cancer Treatment: Where Are We?International journal of molecular sciences · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer.
methodsRandomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration.
resultsEighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms.
conclusionsTreatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.
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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.