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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Chinese Medicine Oral Rinse Formula-I (CMORF-I)
Standard Care
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who are aged ≥18, with known diagnosis of non-metastatic hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, and salivary gland cancer. are the first time to receive RT to the primary tumor in the area of the head or face, neck, or oral cavity. start RT recently within 14 days. are assessed by CMPs for the condition of oral mucositis according to modified World Health Organization (WHO) Mucositis Grades with Grade ≦1. have Karnofsky Performance Status (KPS) ≥ 60 (patients require occasional assistance, but is able to care for most personal needs will be 60 or above). are able to read or understand and sign the consent form. Exclusion Criteria: Patients who receive concurrent chemo-radiation. have known medication on bacterial or fungal infections of oropharynx at recruitment. have other known diseases such as serious and uncontrolled Diabetes mellitus (with symptom of delayed wound healing over the past half year) or hyperthyroidism (with symptom of serious oral dryness over the past half year), known connective vascular disorders or known Human Immunodeficiency Virus (HIV) infections etc. have known history of allergy to CMORF-I ingredients or Glucose-6-Phosphate Dehydrogenase (G6PD) patients. are known pregnant or breastfeeding.

Sites / Locations

  • Hong Kong Institute of Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group: Chinese Medicine Oral Rinse and Standard Care

Control Group: Placebo and Standard Care

Arm Description

Prescription and oral rinsing with Chinese Medicine Oral Rinse Formula-I (CMORF-I) which mainly consists of the Nong's concentrated CM granules of Wu Wei Xiao Du Yin and other ingredients. Standard care will be following the indications provided by patient's western medical doctor. Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.

Placebo: The placebo consists of an inert substance, made of starch filler, flavor and colorings. It is also manufactured under GMP standard. To ensure blinding, the CMORF-I formula and placebo will be indistinguishable in appearance, smell and favour. Standard care will be following the indications provided by patient's western medical doctor. Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.

Outcomes

Primary Outcome Measures

Comparison of the proportion of the most severe modified WHO Mucositis Grades
Comparison of the proportion of the most severe modified WHO Mucositis Grades among intervention and control groups during RT. Grades of the OM will be assessed by a Registered Chinese medicine practitioner (CMP) at baseline and day 7 (±1d) of every week during the RT, the most severe grades during the treatment will be regarded for data analysis. Modified WHO Mucositis Grading Scale: Grade 0 (none) - normal; Grade 1 (mild) - soreness/erythema; Grade 2 (moderate) - erythema, ulcer/pseudo-membranes, can eat solids (erythema with ulcers less than 1 cm); Grade 3 (severe) - ulcer/pseudo-membrane, (erythema with ulcers more than 1cm) requires liquid diet only; Grade 4 (life-threatening) - ulcer with hemorrhage and necrosis, alimentation not possible; cancer treatment that results in or contribute to death is reported separately.

Secondary Outcome Measures

10cm visual analogue scale (VAS) of oral pain
It is a measurement of oral pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left and "worst pain" on the right.
Oral Mucositis Daily Questionnaire (OMDQ) (validated Chinese version with modification)
It is a measurement of self-reported quality of life. It contains 10 items, for most questions in the OMDQ, a higher score indicated a worsening in symptom severity or more interference with functional activity. For the question pertaining to overall health, a higher score indicates better overall health status.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-C30) (Hong Kong Cantonese version)
It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 30 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-H&N35) (Hong Kong Cantonese version)
It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 35 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".
Body mass index (BMI)
It is a measurement of the amount of body fat based on height and weight that applies to adult men and women. It can assess and monitor the risk of OM to a certain extent.
Number of analgesic and antibiotics use daily
It can assess and monitor the conditions of OM.

Full Information

First Posted
November 6, 2022
Last Updated
December 16, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05664906
Brief Title
Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients
Official Title
Evaluating Efficacy and Safety of Chinese Medicine Oral Rinse in Treating and Preventing Irradiated Oral Mucositis in Head-and-Neck Cancer Patients - a Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. The risk of OM is especially high in NPC patients who receive concomitant chemotherapy, receive a total dose over 5,000 Gy, treat with altered fractionation radiation schedules, have bad oral hygiene status, do not use antibiotic at early stage mucositis, have smoking history, drink alcohol, have problems in nutritional status like anorexia, malnutrition, lack of vitamins, restriction of food due to specific dietary requirements, have haematological disease or non-ideal hematological status, have advanced localization of tumors and stage, receive immunotherapy, have pre-existing dry mouth (Xerostomia), have episodes of OM during prior treatment cycles and low BMI, etc. According to some weighed guidelines such as The Multinational Association of Supportive Care in Cancer and International Society for Oral Oncology (MASCC/ISOO) guidelines for the management of OM, recent systematic reviews and researches, there are mainly several sections for intervention: (1) Basic oral care, (2) Anti-inflammatory agents, (3) Photobiomodulation, (4) Cryotherapy, (5) Antimicrobials, coating agents, anesthetics, and analgesics, (6) Growth factors and cytokines, and (7) Natural and miscellaneous. We can summarize several suggestions for the prevention of OM in H&N cancer adults receiving RT from the above protocols: multiagent combination oral care protocols (increasing the awareness of good oral hygiene), professional dental care (a desirable option before or during cancer therapy for local and systemic infections from odontogenic sources), benzydamine mouthwash (as the anti-inflammaotary agents for moderate dose of RT (<50 Gy)) and intraoral photobiomodulation therapy using low-level laser therapy. Over the years, the number of interventions studied for OM and their quality of study design have been dramatically increasing. However, since there are still some advantages and disadvantages for some suggested agents, some clinical settings have not yet been recommended with appropriate intervention. Natural and miscellaneous agents are also reviewed in the past years while honey is suggested for prevention of OM in patients with H&N cancer who receive treatment with either RT or chemo-RT. However, if honey is applied repeatedly on a daily basis for a longer period, we have to be cautions with its deleterious effects. A strict oral hygiene protocol has to be followed to prevent dental caries. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Oral Mucositis (Ulcerative) Due to Radiation, Chinese Medicine Oral Rinse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled pilot study will be employed, participants will receive either CM Oral Rinse granules (CMORF-I) or placebo while they will receive standard care too. Since the duration of RT and recruitment time may vary, the intervention period starts from baseline (14 days within RT starts) to 2 weeks after the end of RT, while the post-intervention period will be 10 weeks starting from 2 weeks after the end of RT with 3 post-intervention follow-up visits (4 weeks, 8 weeks and 12 weeks after the end of RT).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group: Chinese Medicine Oral Rinse and Standard Care
Arm Type
Active Comparator
Arm Description
Prescription and oral rinsing with Chinese Medicine Oral Rinse Formula-I (CMORF-I) which mainly consists of the Nong's concentrated CM granules of Wu Wei Xiao Du Yin and other ingredients. Standard care will be following the indications provided by patient's western medical doctor. Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.
Arm Title
Control Group: Placebo and Standard Care
Arm Type
Placebo Comparator
Arm Description
Placebo: The placebo consists of an inert substance, made of starch filler, flavor and colorings. It is also manufactured under GMP standard. To ensure blinding, the CMORF-I formula and placebo will be indistinguishable in appearance, smell and favour. Standard care will be following the indications provided by patient's western medical doctor. Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.
Intervention Type
Drug
Intervention Name(s)
Chinese Medicine Oral Rinse Formula-I (CMORF-I)
Other Intervention Name(s)
CMORF-I
Intervention Description
Prescription of Chinese Medicine Oral Rinse Formula-I (CMORF-I) Instruction to rinse: The above amount of concentrated CM granules will be divided and packed in 4 bags per day. Dissolve 1 bag of concentrated CM granules with 150ml 80'C boiled hot water, and wait for 20 mins to cool down. Clean the mouth thoughtfully by rinsing with 150ml of distilled water for 2 minutes. 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. 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. 4 times a day (half an hour after every meal, half an hour before sleep), from baseline to 2 weeks after RT.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
• Standard care including normal saline or medical mouthwash, optional analgesics and antibiotics will be offered by hospital.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo granules, instruction is the same as CMORF-I.
Primary Outcome Measure Information:
Title
Comparison of the proportion of the most severe modified WHO Mucositis Grades
Description
Comparison of the proportion of the most severe modified WHO Mucositis Grades among intervention and control groups during RT. Grades of the OM will be assessed by a Registered Chinese medicine practitioner (CMP) at baseline and day 7 (±1d) of every week during the RT, the most severe grades during the treatment will be regarded for data analysis. Modified WHO Mucositis Grading Scale: Grade 0 (none) - normal; Grade 1 (mild) - soreness/erythema; Grade 2 (moderate) - erythema, ulcer/pseudo-membranes, can eat solids (erythema with ulcers less than 1 cm); Grade 3 (severe) - ulcer/pseudo-membrane, (erythema with ulcers more than 1cm) requires liquid diet only; Grade 4 (life-threatening) - ulcer with hemorrhage and necrosis, alimentation not possible; cancer treatment that results in or contribute to death is reported separately.
Time Frame
From baseline to week 12 after the end of RT during post intervention period
Secondary Outcome Measure Information:
Title
10cm visual analogue scale (VAS) of oral pain
Description
It is a measurement of oral pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left and "worst pain" on the right.
Time Frame
Day 3 and day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.
Title
Oral Mucositis Daily Questionnaire (OMDQ) (validated Chinese version with modification)
Description
It is a measurement of self-reported quality of life. It contains 10 items, for most questions in the OMDQ, a higher score indicated a worsening in symptom severity or more interference with functional activity. For the question pertaining to overall health, a higher score indicates better overall health status.
Time Frame
Day 3 and day 7 (±1d) of every week during intervention period, once a week during post intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.
Title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-C30) (Hong Kong Cantonese version)
Description
It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 30 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".
Time Frame
Day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.
Title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-H&N35) (Hong Kong Cantonese version)
Description
It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 35 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".
Time Frame
Day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.
Title
Body mass index (BMI)
Description
It is a measurement of the amount of body fat based on height and weight that applies to adult men and women. It can assess and monitor the risk of OM to a certain extent.
Time Frame
From baseline to week 12 after the end of RT during post intervention period
Title
Number of analgesic and antibiotics use daily
Description
It can assess and monitor the conditions of OM.
Time Frame
From baseline to week 12 after the end of RT during post intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are aged ≥18, with known diagnosis of non-metastatic hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, and salivary gland cancer. are the first time to receive RT to the primary tumor in the area of the head or face, neck, or oral cavity. start RT recently within 14 days. are assessed by CMPs for the condition of oral mucositis according to modified World Health Organization (WHO) Mucositis Grades with Grade ≦1. have Karnofsky Performance Status (KPS) ≥ 60 (patients require occasional assistance, but is able to care for most personal needs will be 60 or above). are able to read or understand and sign the consent form. Exclusion Criteria: Patients who receive concurrent chemo-radiation. have known medication on bacterial or fungal infections of oropharynx at recruitment. have other known diseases such as serious and uncontrolled Diabetes mellitus (with symptom of delayed wound healing over the past half year) or hyperthyroidism (with symptom of serious oral dryness over the past half year), known connective vascular disorders or known Human Immunodeficiency Virus (HIV) infections etc. have known history of allergy to CMORF-I ingredients or Glucose-6-Phosphate Dehydrogenase (G6PD) patients. are known pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KWOK YIN AU, Doctor of Medicine
Phone
+852 28733100
Email
davidau@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KWOK YIN AU, Doctor of Medicine
Organizational Affiliation
Hong Kong Institute of Integrative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Institute of Integrative Medicine
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KWOK YIN AU, PhD
Phone
+852 28733100
Email
davidau@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients

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