Head and Neck CancerPhase 2NCT05040425
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
A Phase 2 study testing Zi-Yin-Liang-Ge-San in people with Head and Neck Cancer and Oral Mucositis, run by Chang Gung Memorial Hospital.
Trial summary
This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis
- What is being tested?
- Zi-Yin-Liang-Ge-San
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2021to 1 Apr 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven stage II-IV squamous HNC
- Indication for radiotherapy or radio-chemotherapy
- No history of antitumor therapies
- No history of oral ulcer and salivary gland diseases
- Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Who cannot join
- Terminal cancer for which aggressive treatments were not suitable
- Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit)
- Uncontrolled psychiatric problems or altered mental status
- Had received medications for other clinical trials
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
Read the detailed description
200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H\&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Being tested
- Zi-Yin-Liang-Ge-San
- Keywords
- Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zi-Yin-Liang-Ge-SanDrug
Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP).
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine treatment | Experimental | Not described Receives: Drug: Zi-Yin-Liang-Ge-San |
| Non-Chinese herbal medicine treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of oral mucositis
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: During the radiotherapy course, up to 6 weeks
Mucositis pain
100-mm-visual analog scale (VAS, 0-100)
Measured: During the radiotherapy course, up to 6 weeks
Secondary outcomes (3)
Health related-QoL (1)
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Measured: Baseline, 4th week, and 6th week of radiotherapy completion
Health related-QoL (2)
Quality of Life Head and Neck Module (QLQ-H\&N35)
Measured: Baseline, 4th week, and 6th week of radiotherapy completion
Body mass index (BMI)
Body mass index (BMI)
Measured: During the radiotherapy course, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start30 Aug 2021 (estimated)
- Primary completion17 Aug 2022 (estimated)
- Study completion1 Apr 2023 (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 CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants selected at screening who provide written informed consent will be randomly allocated to two groups. One will be submitted to Chinese herbal medicine group, and the other to control group.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040425
- Sponsor's protocol ID
- 202101231A3
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT05040425
- Acronym / sponsor ID
- 202101231A3
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Keywords
- Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 10 Sep 2021 (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.
This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
Detailed description
200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H\&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants selected at screening who provide written informed consent will be randomly allocated to two groups. One will be submitted to Chinese herbal medicine group, and the other to control group.
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine treatment | Experimental | Drug: Zi-Yin-Liang-Ge-San |
| Non-Chinese herbal medicine treatment | No intervention | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven stage II-IV squamous HNC
- Indication for radiotherapy or radio-chemotherapy
- No history of antitumor therapies
- No history of oral ulcer and salivary gland diseases
- Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Key exclusion criteria (4 listed)
- Terminal cancer for which aggressive treatments were not suitable
- Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit)
- Uncontrolled psychiatric problems or altered mental status
- Had received medications for other clinical trials
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 |
|---|---|---|
| Zi-Yin-Liang-Ge-SanZi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP). | Drug | Chinese herbal medicine treatment |
Primary outcome
Degree of oral mucositis
Time frame: During the radiotherapy course, up to 6 weeks
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Mucositis pain
Time frame: During the radiotherapy course, up to 6 weeks
100-mm-visual analog scale (VAS, 0-100)
3 secondary outcomes
Health related-QoL (1)
Time frame: Baseline, 4th week, and 6th week of radiotherapy completion
Health related-QoL (2)
Time frame: Baseline, 4th week, and 6th week of radiotherapy completion
Body mass index (BMI)
Time frame: During the radiotherapy course, up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No. The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zi-Yin-Liang-Ge-San in people with Head and Neck Cancer and Oral Mucositis, run by Chang Gung Memorial Hospital.
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 5 inclusion and 4 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 10 Sep 2021. 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. 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 Ming-Yen Tsai, PhD (+886975056534, missuriae@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of oral mucositis (time frame: During the radiotherapy course, up to 6 weeks). The study lists 2 primary outcomes in all. 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 10 Sep 2021.