Sancai Fengsui Decoction for RTOM: A Multicenter RCT
3 juillet 2026 mis à jour par: Nanfang Hospital, Southern Medical University
A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
How to promote the prognosis and outcome of RTOM, restore oral function, and improve quality of life are key issues for improving the long-term outcomes of head and neck malignant tumor radiotherapy, and are also integral parts of the patient-centered Traditional Chinese Medicine "prevention-treatment-rehabilitation" system for RTOM.
This project aims to thoroughly evaluate the efficacy and safety of Chinese herbal compounds in the rehabilitation phase of RTOM, targeting the long-term rehabilitation outcomes of RTOM, and to conduct a phase II clinical trial.
In this project, Sancai Fengsui Decoction will be used as an oral medication to improve the rehabilitation status of RTOM, and will be compared with a placebo group.
The efficacy of the oral medication will be evaluated by comparing outcome measures including the 2-week pain relief rate in the oral cavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate of xerostomia.
As an important extension of TCM prevention and treatment for RTOM, this project can provide a high-level evidence-based TCM protocol for the long-term rehabilitation of RTOM.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
126
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jian Guan, PhD
- Numéro de téléphone: 020-62787238Guanj@smu.edu.cn
- E-mail: Guanj@smu.edu.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Meets the diagnostic criteria for RTOM, with severity classified according to the RTOG grading system;
- Voluntarily participates in this study and signs the informed consent form;
- Age between 18 and 65 years;
- Histopathologically diagnosed with non-metastatic head and neck malignancy;
- Has received radiotherapy or concurrent chemoradiotherapy;
- ECOG performance status score: 0-2;
- Adequate major organ function.
- Exclusion Criteria:
- Patients with severe heart, lung, liver, kidney, digestive system, hematopoietic system, or nervous system diseases; acute infectious diseases; autoimmune diseases; HIV; diabetes mellitus with poor blood glucose control; or any other serious condition that, in the investigator's judgment, may increase the risk of the study, interfere with study execution or result analysis, or make the subject unsuitable for enrollment for other reasons;
- Pregnant or breastfeeding women;
- Allergic constitution;
- Patients with severe psychiatric disorders, or a history of alcohol or drug abuse;
- Participation in another clinical trial within the past 3 months;
- Subjects deemed unsuitable for participation in this clinical study by the investigator.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sancai Fengshui Tang group
Sancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks.
|
To investigate the efficacy of Sancai Fengsui Decoction in the treatment of RTOM，orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks.
|
|
Comparateur placebo: Placebo control group
Placebo group: The control group received a placebo that matched the color, odor, and taste of the Sancai Fengsui Decoction but contained no active ingredients of the decoction.
The usage and dosage were the same as those in the Sancai Fengsui Decoction group.
|
The control group received a placebo that matched the color, odor, and taste of the Sancai Fengsui Decoction but contained no active ingredients of the decoction.
The usage and dosage were the same as those in the Sancai Fengsui Decoction group.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain relief rate in the oral cavity/oropharynx
Délai: Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).
|
The proportion of patients achieving a clinically significant improvement in pain intensity from baseline to 2 weeks post-enrollment, as assessed by the Numeric Rating Scale (NRS).
Complete response (CR) was defined as a pain score of 0 (no pain), and partial response (PR) was defined as either a reduction of at least 2 points from baseline on the NRS or an improvement by one pain category, according to the following NRS classification: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
|
Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
RTOG score remission rate of RTOM
Délai: Evaluated at 2 weeks post-radiotherapy
|
The proportion of patients with a reduction of at least 1 grade in mucosal reaction at 2 weeks after radiotherapy, according to the RTOG acute radiation morbidity grading criteria (complete response defined as return to grade 0, partial response as reduction by at least 1 grade).
|
Evaluated at 2 weeks post-radiotherapy
|
|
3-month xerostomia relief rate
Délai: From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.
|
To evaluate the proportion of patients who achieve a clinically significant improvement in subjectively reported xerostomia severity over the 3-month period, as assessed by the xerostomia questionnaire.
|
From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.
|
|
Analgesic medication use
Délai: Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.
|
By reviewing patients' medication diaries and medical records, we analyzed changes in the average daily dosage and frequency of analgesic use, as well as cases of dose reduction or drug discontinuation.
|
Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.
|
|
Usage of nutrient solutions/nutritional powders
Délai: Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.
|
Consumption records of nutritional support products were collected to analyze the proportion of patients dependent on enteral nutrition support, as well as changes in usage volume and duration
|
Baseline (screening/enrollment), week 1 and week 2 of the treatment period, weeks 1 through 6 of the follow-up period (weekly), and week 10 of the follow-up period.
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Délai: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its head and neck cancer module (QLQ-H&N35) were adopted to evaluate the improvement in overall quality-of-life scores and scores of specific domains (e.g., fatigue, swallowing function)
|
Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
|
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35
Délai: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its head and neck cancer module (QLQ-H&N35) were adopted to evaluate the improvement in overall quality-of-life scores and scores of specific domains (e.g., fatigue, swallowing function)
|
Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 janvier 2028
Achèvement de l'étude (Estimé)
31 juillet 2028
Dates d'inscription aux études
Première soumission
7 juin 2026
Première soumission répondant aux critères de contrôle qualité
3 juillet 2026
Première publication (Réel)
9 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NFEC-2026-211
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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