Radiation-Induced Oral Mucositis (RTOM)Phase 2NCT07692997
Sancai Fengsui Decoction for RTOM: A Multicenter RCT
A Phase 2 study testing Sancai Fengsui Decoction in people with Radiation-Induced Oral Mucositis (RTOM) and Head and Neck Cancer, run by Nanfang Hospital, Southern Medical University.
Trial summary
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"… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation-Induced Oral Mucositis (RTOM), Head and Neck Cancer, Oral Mucositis of RTOG Grade Greater Than 1
- What is being tested?
- Sancai Fengsui Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Radiation-Induced Oral Mucositis (RTOM), Head and Neck Cancer, Oral Mucositis of RTOG Grade Greater Than 1
- Being tested
- Sancai Fengsui Decoction, Placebo Group
- Keywords
- Head and neck tumors, Radiation-induced oropharyngeal mucositis, Traditional Chinese Medicine (TCM) rehabilitation, phase II, double-blind, two-arm (1:1), clinical trial
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sancai Fengsui DecoctionDrug
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 GroupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sancai Fengshui Tang group | Experimental | Sancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks. Receives: Drug: Sancai Fengsui Decoction |
| Placebo control group | Placebo comparator | 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. Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief rate in the oral cavity/oropharynx
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).
Measured: Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).
Secondary outcomes (6)
RTOG score remission rate of RTOM
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).
Measured: Evaluated at 2 weeks post-radiotherapy
3-month xerostomia relief rate
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.
Measured: From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.
Analgesic medication use
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.
Measured: 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
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
Measured: 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
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)
Measured: 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
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)
Measured: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced Oral Mucositis (RTOM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692997
- Sponsor's protocol ID
- NFEC-2026-211
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial to Evaluate the Rehabilitative Efficacy of Sancai Fengsui Decoction on Radiation-Induced Oral Mucositis.
- ClinicalTrials.gov ID
- NCT07692997
- Acronym / sponsor ID
- NFEC-2026-211
- Conditions
- Radiation-Induced Oral Mucositis (RTOM), Head and Neck Cancer, Oral Mucositis of RTOG Grade Greater Than 1
- Keywords
- Head and neck tumors, Radiation-induced oropharyngeal mucositis, Traditional Chinese Medicine (TCM) rehabilitation, phase II, double-blind, two-arm (1:1), clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sancai Fengshui Tang group | Experimental | Drug: Sancai Fengsui DecoctionSancai Fengsui Decoction group: Orally administered Sancai Fengsui Decoction, 30 mL per dose, three times daily, with a treatment course of two weeks. |
| Placebo control group | Placebo comparator | Drug: Placebo GroupPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sancai Fengsui DecoctionTo 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. | Drug | Sancai Fengshui Tang group |
| Placebo GroupThe 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. | Drug | Placebo control group |
Primary outcome
Pain relief rate in the oral cavity/oropharynx
Time frame: 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).
6 secondary outcomes
RTOG score remission rate of RTOM
Time frame: Evaluated at 2 weeks post-radiotherapy
3-month xerostomia relief rate
Time frame: From enrollment (Day 0) through Month 3, spanning the entire radiotherapy treatment period.
Analgesic medication use
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Radiation-Induced Oral Mucositis (RTOM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sancai Fengsui Decoction in people with Radiation-Induced Oral Mucositis (RTOM) and Head and Neck Cancer, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan, PhD (020-62787238Guanj@smu.edu.cn, Guanj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief rate in the oral cavity/oropharynx (time frame: Proportion of patients with significant improvement in pain level from baseline at 2 weeks after enrollment, assessed using the Numeric Rating Scale (NRS).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.