Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2013
SAMITAL® improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 5 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
13 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Systematic review of prophylactic antibacterial agents for radiation-induced oral mucositis in head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Pooled it
- Medicinal plants used for the treatment of mucositis induced by oncotherapy: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Pooled it
- The effectiveness of mouthwashes in alleviating radiation-induced oral mucositis in head and neck cancer patients: a systematic review.Oral radiology · 2019Pooled it
- Systematic Review of the Use of Phytochemicals for Management of Pain in Cancer Therapy.BioMed research international · 2015Pooled it
- Plant Bioactive Constituents and Their Potential Benefits in HPV-Positive Oropharyngeal Squamous Cell Carcinoma-A Narrative Review.Current issues in molecular biology · 2026Review
- Oral Health and Nutraceutical Agents.International journal of molecular sciences · 2024Review
- Importance of phytotherapy for oral health care and quality of life in adults: A scoping review.Journal of dental sciences · 2024Article
- Interventions to improve quality of life in patients with head and neck cancers receiving radiation therapy: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Article
- Article
- Formulation and Development of Bioadhesive Oral Films ContainingPharmaceutics · 2022Article
- Anticancer Effects of Lingonberry and Bilberry on Digestive Tract Cancers.Antioxidants (Basel, Switzerland) · 2021Review
- Integrative Therapy Use for Management of Side Effects and Toxicities Experienced by Pediatric Oncology Patients.Children (Basel, Switzerland) · 2014Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis randomised, placebo-controlled single-blind trial investigated the safety and efficacy of SAMITAL®, a formulation of highly standardised botanical extracts, in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer.
methodsPatients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy. Severity of OM was monitored according to a modified WHO severity scale, and pain and quality-of-life assessments were based on the effect of symptoms of OM on relevant daily activities, according to a visual analogue scale.
resultsMean scores for the severity of OM were significantly (p < 0.05 versus baseline) reduced from day 31 until the end of treatment in patients treated with SAMITAL® (n = 20). No significant improvement was observed in the placebo group (n = 10). Pain reduction was significant from day 4 till end of treatment with SAMITAL® and from days 7 to 21 in placebo patients. SAMITAL® also significantly improved quality of life, as shown by improvements in scores for relevant daily activities including eating, drinking and sleeping. All SAMITAL® patients completed the treatment period, but no placebo recipients completed treatment. No severe adverse events were observed with SAMITAL®, and systemic absorption of relevant active ingredients was undetectable.
conclusionsSAMITAL® significantly decreased the severity of chemo/radiotherapy-induced OM in patients with head and neck cancer, with no treatment-related adverse events. Pain relief lasted through the treatment period, and improvements in quality of life were reflected by the significant benefits of SAMITAL® on activities like drinking, eating and speaking.
Indexed as
Identifiers
22945882What 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.