Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2012
A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 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
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 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
- Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013Pooled it
- The effects of Ankaferd hemostat on preventing oral mucositis in colorectal cancer patients receiving chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Trial
- Photobiomodulation at Multiple Wavelengths Differentially Modulates Oxidative StressOxidative medicine and cellular longevity · 2018Trial
- Systemic Anti-Inflammatory Agents in the Prevention of Chemoradiation-Induced Mucositis: A Review of Randomised Controlled Trials.Biomolecules · 2024Review
- New Frontiers in the Pathobiology and Treatment of Cancer Regimen-Related Mucosal Injury.Frontiers in pharmacology · 2017Review
- Treatment of oral mucositis due to chemotherapy.Journal of clinical and experimental dentistry · 2016Review
- Review of preclinical studies on treatment of mucositis and associated pain.Journal of dental research · 2014Review
- Emerging targets in lipid-based therapy.Biochemical pharmacology · 2013Review
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
purposeMisoprostol, a synthetic analog of prostaglandin E1, has anti-inflammatory and mucosa-protecting properties. The objective of this study was to evaluate the efficacy of misoprostol oral rinse in reducing the severity of oral mucosal injury caused by high-dose chemotherapy.
methodsThe study used a randomized, double-blind, placebo-controlled, parallel-group design. Oncology patients receiving myeloablative high-dose chemotherapy, in preparation for a hematopoietic stem cell transplant, were randomized to misoprostol or placebo rinse. The primary outcome measure was the severity of oral mucositis, measured using the modified Oral Mucositis Index. Additional outcome measures included the severity of mouth pain (measured using a Visual Analog Scale and the Pain Affect Faces Scale), duration of hospital stay, and days on total parenteral nutrition.
resultsThis study was originally planned to accrue 160 subjects but was terminated early due to revised sponsor research priorities. The intent-to-treat population consisted of 22 subjects randomized to misoprostol rinse and 26 subjects randomized to placebo rinse. There was no significant difference between the two groups in mucositis or pain severity. In both groups, duration of hospital stay was approximately 19 days, and number of days on total parenteral nutrition was 17-18 days. There were no serious adverse events attributable to misoprostol rinse.
conclusionsAlthough this study did not find a beneficial effect of a misoprostol rinse in mucositis secondary to high-dose chemotherapy, the small sample size limits the strength of this conclusion. Given the proposed importance of the prostaglandin pathway in the pathogenesis of oral mucositis, additional studies are warranted.
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