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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
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.
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.
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).
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).
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).
Time frame: 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.
Time frame: 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.
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
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
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
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)
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
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)
Time frame: Baseline (screening), treatment week 2, and follow-up weeks 2, 6, and 10
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