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Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients

NCT05664906 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-12-27

No results posted yet for this study

Summary

Approximately 60% and 90% of patients with head and neck (H\&N) cancers receiving standard radiotherapy (RT) and chemoradiotherapy (chemo-RT) will develop oral mucositis respectively. Oral mucositis (OM) is one of the dose-limiting adverse events which can also lead to emotional and nutritional problems. Clinically, it is usually observed by the end of first week of RT (after 10 Gy) and reaches peak damage in 14-21 days or by the end of treatment. Healing then takes approximately 2 to 3 weeks after completion of RT. For the Chinese Medicine (CM) interventions, many studies have been reviewed on the efficacy of mouthwash or internal herbal decoction to OM. Although some positive results were observed, most of them were performed by applying different assessment tools and lack of quality of life (QOL) or self-reported symptoms assessment. In addition, the intervention time and follow-up period were usually insufficient (stopped at the end of RT), therefore they could not review the long-term efficacy of CM according to normal progression of OM and the safety of using CM. Therefore, we hope this pilot study can evaluate the efficacy and safety of CM in a strict protocol.

Conditions

  • Head and Neck Neoplasms
  • Oral Mucositis (Ulcerative) Due to Radiation
  • Chinese Medicine Oral Rinse

Interventions

DRUG

Chinese Medicine Oral Rinse Formula-I (CMORF-I)

* Prescription of Chinese Medicine Oral Rinse Formula-I (CMORF-I) * Instruction to rinse: 1. The above amount of concentrated CM granules will be divided and packed in 4 bags per day. 2. Dissolve 1 bag of concentrated CM granules with 150ml 80'C boiled hot water, and wait for 20 mins to cool down. 3. Clean the mouth thoughtfully by rinsing with 150ml of distilled water for 2 minutes. 4. Rinse the mouth thoughtfully with one-third of the dissolved and cooled CM oral rinse, gargle, expel after 3 minutes, do not swallow and repeat twice. 5. To ensure better contact of the CM oral rinse in all parts and folds of the oral cavity, our research assistant and CMP will guide the patients to fully agitate the mouth, use the tongue to stir repeatedly among the teeth, cheeks and palate surface, and to raise the tip of the tongue for a moment and tilt the head back. 6. 4 times a day (half an hour after every meal, half an hour before sleep), from baseline to 2 weeks after RT.

OTHER

Standard Care

• Standard care including normal saline or medical mouthwash, optional analgesics and antibiotics will be offered by hospital.

OTHER

Placebo

Placebo granules, instruction is the same as CMORF-I.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • KWOK YIN AU, Doctor of Medicine · Hong Kong Institute of Integrative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-05-31
Completion
2024-11-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664906 on ClinicalTrials.gov