Trial reportCancer chemotherapy and pharmacology2015
Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis.
Trial report in Cancer chemotherapy and pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07736495 (Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients), which is not on this map. Cited by 46 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.
Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients
Who cites it
46 citing papers in PubMed, 4 syntheses or guidelines pooled it, 81 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
- Clinical applicability of natural products for prevention and treatment of oral mucositis: a systematic review and meta-analysis.Clinical oral investigations · 2021Pooled it
- Efficacy of Herbal Medicines Intervention for Colorectal Cancer Patients With Chemotherapy-Induced Gastrointestinal Toxicity - a Systematic Review and Meta-Analysis.Frontiers in oncology · 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
- Hangeshashinto for prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized phase II study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Trial
- 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
- Potential pharmacological quality control markers in the traditional Japanese medicine Hangeshashinto: identifying anti-inflammatory ingredients through a cell-based bioassay and multicomponent analysis.Pharmaceutical biology · 2025Article
- Effects of Natural Health Products in Combination with FP-Based Chemotherapy.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Gut microbiota in cancer initiation, development and therapy.Science China. Life sciences · 2025Review
- Reunderstanding the classical prescription Banxia Xiexin Decoction: new perspectives from a comprehensive review of clinical research and pharmacological studies.Chinese medicine · 2025Review
- Two Cases and a Review of the Literature Regarding Severe Interstitial Lung Disease Induced by Hangeshashinto.Internal medicine (Tokyo, Japan) · 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
- The Impact of Hangeshashinto on Symptoms and Gut Microbiota in Diarrhea-type Irritable Bowel Syndrome: A Retrospective Analysis.Journal of the anus, rectum and colon · 2025Article
- Hangeshashinto InhibitsEvidence-based complementary and alternative medicine : eCAM · 2024Article
- The role of pharmacists in multimodal cancer cachexia care.Asia-Pacific journal of oncology nursing · 2023Review
- 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
- Perspectives of international multi-center clinical trials on traditional Chinese herbal medicine.Frontiers in pharmacology · 2023Review
- Development of Kampo（traditional Japanese medicine）e-learning program: evaluation of the flipped classroom for medical students.Medical education online · 2021Article
Corrections and comments
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Authors and funding
10 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeHangeshashinto (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 double-blind, placebo-controlled, randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with colorectal cancer.
methodsNinety-three patients with colorectal cancer who developed moderate-to-severe COM (WHO grade ≧1) during any cycle of chemotherapy using FOLFOX, FOLFIRI, and/or XELOX treatment were randomly assigned to receive either TJ-14 (n = 46) or placebo (n = 47). Patients received the administration of placebo or TJ-14 for 2 weeks at the start of the next course of chemotherapy. Patients were assessed three times per week for safety and for COM incidence and its severity using the WHO grading.
resultsNinety eligible patients (TJ-14; 43, placebo; 47) per protocol set analysis were included in the analysis after the key-opening. Although the incidence of grade ≧2 oral mucositis was lower for patients treated with TJ-14 compared to those treated with placebo, there was no significant difference (48.8 vs. 57.4 %; p = 0.41). The median duration of grade ≧2 mucositis was 5.5 versus 10.5 days (p = 0.018). No difference in other treatment toxicity was observed between the two groups, and patients exhibited high compliance in dosing administration.
conclusionThe present study results did not meet the primary endpoint. However, TJ-14 demonstrated a significant effect in the treatment of grade ≧2 mucositis in patients with colorectal cancer compared to the placebo.
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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.