Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Sancai Fengsui Decoction for RTOM: A Multicenter RCT

3 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

126

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jian Guan, PhD
  • Telefoonnummer: 020-62787238Guanj@smu.edu.cn
  • E-mail: Guanj@smu.edu.cn

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Sancai Fengsui Decoction
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.
Placebo-vergelijker: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain relief rate in the oral cavity/oropharynx
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
RTOG score remission rate of RTOM
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanfang Hospital, Southern Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 januari 2028

Studie voltooiing (Geschat)

31 juli 2028

Studieregistratiedata

Eerst ingediend

7 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NFEC-2026-211

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren