Trial reportCancer chemotherapy and pharmacology2014
Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis.
Trial report in Cancer chemotherapy and pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 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
30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Hangeshashinto for the prevention of oral mucositis in patients receiving chemotherapy: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Efficacy of traditional Chinese medicine combined with chemotherapy for gastric cancer and precancerous gastric lesions: a systematic review and meta-analysis.Frontiers in oncology · 2026Pooled it
- Clinical applicability of natural products for prevention and treatment of oral mucositis: a systematic review and meta-analysis.Clinical oral investigations · 2021Pooled it
- Systematic review of natural and miscellaneous agents, for the management of oral mucositis in cancer patients and clinical practice guidelines - part 2: honey, herbal compounds, saliva stimulants, probiotics, and miscellaneous agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Pooled it
- Trial
- Efficacy and safety of hangeshashinto for treatment of GERD refractory to proton pump inhibitors : Usual dose proton pump inhibitors plus hangeshashinto versus double-dose proton pump inhibitors: randomized, multicenter open label exploratory study.Journal of gastroenterology · 2019Trial
- Integrative In Silico and In Vivo Analysis of Banhasasim-Tang for Irritable Bowel Syndrome: Mechanistic Insights into Inflammation-Related Pathways.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Reunderstanding the classical prescription Banxia Xiexin Decoction: new perspectives from a comprehensive review of clinical research and pharmacological studies.Chinese medicine · 2025Review
- Trends in Kampo Medicine Usage as Supportive Care During Anticancer Drug Treatment in Japanese Patients: A Nationwide Cohort Analysis from Fiscal Years 2015 to 2021.Current oncology (Toronto, Ont.) · 2025Article
- Prolonged survival by combination treatment with a standardized herbal extract from Japanese Kampo-medicine (Juzentaihoto) and gemcitabine in an orthotopic transplantation pancreatic cancer model.Frontiers in oncology · 2024Article
- Interactions between natural products and cancer treatments: underlying mechanisms and clinical importance.Cancer chemotherapy and pharmacology · 2023Review
- Preparation and pharmaceutical properties of Hangeshashinto oral ointment and its safety and efficacy in Syrian hamsters with 5-fluorouracil-induced oral mucositis.Journal of natural medicines · 2023Article
- How to transfer traditional knowledge about medicinal herbs? or TCM plants: a black box for modern oncologists.Journal of cancer research and clinical oncology · 2021Review
- Plant Extracts as Possible Agents for Sequela of Cancer Therapies and Cachexia.Antioxidants (Basel, Switzerland) · 2020Review
- How to bridge the gap? European medical plants used for treating oral mucositis: on the search for evidence.Journal of cancer research and clinical oncology · 2020Article
- Effects of Topical Hangeshashinto (TJ-14) on Chemotherapy-Induced Oral Mucositis.Cancer management and research · 2020Article
- Beneficial Biological Activities ofBiomedicines · 2020Review
- The clinical effect of Kampo medicine in multimodal treatment for Gastrointestinal Cancer in Japan.Journal of Cancer · 2020Review
- Kampo (Traditional Japanese Herbal) Formulae for Treatment of Stomatitis and Oral Mucositis.Medicines (Basel, Switzerland) · 2018Review
- The Biological Efficacy of Natural Products against Acute and Chronic Inflammatory Diseases in the Oral Region.Medicines (Basel, Switzerland) · 2018Review
Corrections and comments
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Authors and funding
11 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHangeshashinto (TJ-14, a Kampo medicine), which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, alleviates chemotherapy-induced oral mucositis (COM). We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer.
methodsWe randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The patients received a placebo or TJ-14 for 2-6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events.
resultsFollowing the key opening of the blinding protocol, we analyzed 91 eligible patients (TJ-14: 45, placebo: 46) using a "per protocol set" analysis. The incidence of ≧grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group (p = 0.588). The median duration of ≧grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group (p = 0.894). Meanwhile, the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [hazard ratio 0.60; 95 % CI (0.23-1.59), p = 0.290].
conclusionsAlthough TJ-14 treatment did not reduce the incidence of ≥2 COM in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle. Further, phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM.
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