Head and Neck NeoplasmsPhase 2NCT05341206
Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
A Phase 2 study testing Herbal gargle and Normal saline in people with Head and Neck Neoplasms and Chemoradiotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Chemoradiotherapy, Stomatitis and Ulceration
- What is being tested?
- Herbal gargle and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to join the trial project and sign the informed consent form.
- Age more than 20 years-old.
- Pathology proved to be head and neck cancers.
- Head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy.
- Expected life expectancy more than 3 months.
- Subjects with clear consciousness and can be assessed cooperatively.
- Subjects are suitable to use Herbal gargle evaluated by Traditional Chinese medicine physicians.
Who cannot join
- Subjects can not sing the informed consent form.
- Systemic infection.
- Heart, liver and kidney insufficiency
- Allergy history of Traditional Chinese medicine
- Unclear conscious to use Herbal gargle.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Keelung Chang Gung Memorial Hospital
Keelung, Keelung, Taiwan, 20401
Yi-Hsine Shiao, Doctor, 24313131 ext. 2777, vincentking44@gmail.com
About this study
The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.
Read the detailed description
Head and neck cancer accounts for about 5% of all cancers worldwide with the age-standardized incidence rate (ASIR) of HNC increased by 5.4% per year among males and 3.1% among females in Taiwan. Concurrent chemoradiotherapy (CCRT) is the most common management to treat head and neck cancer. However, CCRT may cause much side effects such as oral mucositis, radiation dermatitis, xerostomia, or infection, which influence food intake, disturb nutritional status and interrupt the course of treatment. Traditional Chinese Medicine (TCM) has been applied to treat cancer side effects for many years. Herbal gargle is composed of TCM herbals used for oral mucositis induced by chemoradiotherapy among head and neck cancer. The aim of the trial is to evaluate the effectiveness of Herbal gargle. The participants divide into two groups, treatment group and control group. The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. The control group receive normal saline 150ml for oral mucositis. The subjective questionnaires of EORTC QLQ-C30, EORTC QLQ-H\&N35 are assessed twice a week, CTCAE for grading of oral mucositis is assessed once a week, VAS is assessed everyday for 8 weeks. Besides, change of opioid dosage, body weight are also recorded. The CRP is assessed before and every week for 8 weeks and the albumin and bacteria culture are assessed before and post-treatment of 4th week and 8th week. The baseline difference of treatment and control group will be analyzed by using independent t-test and the difference of evaluation scores and blood tests between pre-treatment and post-treatment will be analyzed using multivariate logistic regression analysis. A value of P < 0.05 will be regarded as statistically significant for the above statistical analyses.
- Being tested
- Herbal gargle, Normal saline
- Keywords
- Medicine, Chinese Traditional, Head and Neck Neoplasms, Chemoradiotherapy, Stomatitis and Ulceration
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal gargleDrug
The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
Normal salineOther
The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. Receives: Drug: Herbal gargle |
| Control group | Sham comparator | The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of CTCAE 4.0
CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy.
Measured: change from baseline and every week for 8 weeks.
Secondary outcomes (8)
Change of EORTC QLQ-C30
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score, EORTC QLQ-C30, is used to measure cancer patients' physical, psychological and social functions.
Measured: change from baseline at 4 weeks and 8 weeks post treatment.
Change of EORTC QLQ-H&N35
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head \& neck, EORTC QLQ-H\&N35, is used for assessing the health-related quality of life for head-and-neck cancer patients.
Measured: change from baseline at 4 weeks and 8 weeks post treatment.
Change of VAS of pain of oral mucositis
Visual Analogue Scale, VAS, is used to to measure the intensity of pain of oral mucositis.
Measured: change from baseline and everyday for 8 weeks.
Change of body weight
The oral mucositis caused by chemoradiotherapy will influence food intake. Monitor body weight provides objective evaluation of nutrition status.
Measured: change from baseline and every week for 8 weeks.
Change of opioid use
Opioid analgesics is often prescribed for alleviating pain from oral mucositis. Monitor opioid use provides other evaluation for severity of pain and wound healing.
Measured: change from baseline and every week for 8 weeks.
Change of albumin
Albumin has been used as maker of nutrition status.
Measured: change from baseline at 4 weeks and 8 weeks post treatment.
Change of CRP
C-reactive protein is used to monitor severity of oral mucositis.
Measured: change from baseline and every week for 8 weeks.
Change of common aerobic culture
Aerobic culture is used to monitor the change of bacteria flora before and after Herbal gargle treatment.
Measured: change from baseline and every week for 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- The treatment group receive Herbal gargle and control group receive normal saline.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341206
- Sponsor's protocol ID
- 202101017A3
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
- ClinicalTrials.gov ID
- NCT05341206
- Acronym / sponsor ID
- 202101017A3
- Keywords
- Medicine, Chinese Traditional, Head and Neck Neoplasms, Chemoradiotherapy, Stomatitis and Ulceration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Apr 2022 (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.
The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.
Detailed description
Head and neck cancer accounts for about 5% of all cancers worldwide with the age-standardized incidence rate (ASIR) of HNC increased by 5.4% per year among males and 3.1% among females in Taiwan. Concurrent chemoradiotherapy (CCRT) is the most common management to treat head and neck cancer. However, CCRT may cause much side effects such as oral mucositis, radiation dermatitis, xerostomia, or infection, which influence food intake, disturb nutritional status and interrupt the course of treatment. Traditional Chinese Medicine (TCM) has been applied to treat cancer side effects for many years. Herbal gargle is composed of TCM herbals used for oral mucositis induced by chemoradiotherapy among head and neck cancer. The aim of the trial is to evaluate the effectiveness of Herbal gargle. The participants divide into two groups, treatment group and control group. The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. The control group receive normal saline 150ml for oral mucositis. The subjective questionnaires of EORTC QLQ-C30, EORTC QLQ-H\&N35 are assessed twice a week, CTCAE for grading of oral mucositis is assessed once a week, VAS is assessed everyday for 8 weeks. Besides, change of opioid dosage, body weight are also recorded. The CRP is assessed before and every week for 8 weeks and the albumin and bacteria culture are assessed before and post-treatment of 4th week and 8th week. The baseline difference of treatment and control group will be analyzed by using independent t-test and the difference of evaluation scores and blood tests between pre-treatment and post-treatment will be analyzed using multivariate logistic regression analysis. A value of P < 0.05 will be regarded as statistically significant for the above statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment group receive Herbal gargle and control group receive normal saline.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Herbal gargleThe treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. |
| Control group | Sham comparator | Other: Normal salineThe control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to join the trial project and sign the informed consent form.
- Age more than 20 years-old.
- Pathology proved to be head and neck cancers.
- Head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy.
- Expected life expectancy more than 3 months.
Key exclusion criteria (5 listed)
- Subjects can not sing the informed consent form.
- Systemic infection.
- Heart, liver and kidney insufficiency
- Allergy history of Traditional Chinese medicine
- Unclear conscious to use Herbal gargle.
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 |
|---|---|---|
| Herbal gargleThe treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. | Drug | Treatment group |
| Normal salineThe control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. | Other | Control group |
Primary outcome
Change of CTCAE 4.0
Time frame: change from baseline and every week for 8 weeks.
CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy.
8 secondary outcomes
Change of EORTC QLQ-C30
Time frame: change from baseline at 4 weeks and 8 weeks post treatment.
Change of EORTC QLQ-H&N35
Time frame: change from baseline at 4 weeks and 8 weeks post treatment.
Change of VAS of pain of oral mucositis
Time frame: change from baseline and everyday for 8 weeks.
Change of body weight
Time frame: change from baseline and every week for 8 weeks.
Change of opioid use
Time frame: change from baseline and every week for 8 weeks.
Change of albumin
Time frame: change from baseline at 4 weeks and 8 weeks post treatment.
Change of CRP
Time frame: change from baseline and every week for 8 weeks.
Change of common aerobic culture
Time frame: change from baseline and every week for 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal gargle and Normal saline in people with Head and Neck Neoplasms and Chemoradiotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hsine Shiao, Doctor (24313131 ext. 2777, vincentking44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of CTCAE 4.0 (time frame: change from baseline and every week for 8 weeks.). 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 22 Apr 2022.