Head and Neck CancerPhase 3NCT02303197
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
A Phase 3 study testing ChiNing decoction in people with Head and Neck Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ChiNing decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Head and neck cancer patients with pathology and / or cytologic diagnosis;
- Age 18~75 years old;
- The expected life is more than 3 months;
- The Karnofsky score (Karnofsky) ≥70 points;
- The first course of radiotherapy in patients;
- Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
- Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme;
- No history of oral ulcer and salivary gland diseases
Who cannot join
- That do not meet the above the inclusion criteria;
- Advanced critical cases, the expected survival is less than 3 months;
- The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
- The submandibular gland pathological changes;
- During radiotherapy taking other drugs in patients with treatment of stomatitis;
- The patients with serious heart, brain, liver, kidney function
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Read the detailed description
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H\&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- ChiNing decoction
- Keywords
- head and neck cancer, chemoradiotherapy, radioactive stomatitis
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiNing decoctionDrug
Also called Addition and subtraction of Liangge San
ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
| Study group | Role | What they receive |
|---|---|---|
| ChiNing decoction | Experimental | 60ml ChiNing decoction by mouth，three times a day for 46 days. Receives: Drug: ChiNing decoction |
| rhEGF spray | No intervention | The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading standard of RTOG in acute radiation injury of oral mucosal
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Measured: 8 days
Secondary outcomes (4)
The visual analogue scale of oral pain
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Measured: 8 days
EORTCQLQ-H&N35
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Measured: 8 days
patient body weight changes
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Measured: 8 days
Safety index
Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cong Wang, Master, Principal investigator, National Clinical Research Center for Cancer of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303197
- Sponsor's protocol ID
- TianjinCIH
- Status last verified
- Oct 2014
- First submitted
- 25 Nov 2014
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ryu SH, Kang KM, Moon SY, Chai GY, Hong JP, Cho KO, Kang MI, Choi EK, Lee SW. Therapeutic effects of recombinant human epidermal growth factor (rhEGF) in a murine model of concurrent chemo- and radiotherapy-induced oral mucositis. J Radiat Res. 2010;51(5):595-601. doi: 10.1269/jrr.10069.
PubMed 20921827Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.
PubMed 16258486Wang B, Cao SH, Wang YQ. [Effects of modified liangge powder contained serum on LPS stimulated TLR4 expression and release of cytokines in mouse platelets]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 May;32(5):681-4. Chinese.
PubMed 22679734Yu LZ, Jiang AD, Cheng YY, Lin H, Qin QH, Ma XD. [Liangge san effects the expression of CD14 and scaverger receptor in the Kupffer cells of liver of endotoxemia mice]. Zhongguo Zhong Yao Za Zhi. 2006 Feb;31(3):220-3. Chinese.
PubMed 16573003Jiang AD, Yu LZ, Gong XW, Deng P, Ma XD. [Effect of Liangge San on lipopolysaccharide-induced nuclear factor kappa B activation in cultured mouse macrophages]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Jun;25(6):619-22. Chinese.
PubMed 15958292
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
- ClinicalTrials.gov ID
- NCT02303197
- Acronym / sponsor ID
- TianjinCIH
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, chemoradiotherapy, radioactive stomatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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 study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Detailed description
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H\&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChiNing decoction | Experimental | Drug: ChiNing decoction60ml ChiNing decoction by mouth，three times a day for 46 days. |
| rhEGF spray | No intervention | –The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Head and neck cancer patients with pathology and / or cytologic diagnosis;
- Age 18~75 years old;
- The expected life is more than 3 months;
- The Karnofsky score (Karnofsky) ≥70 points;
- The first course of radiotherapy in patients;
Key exclusion criteria (6 listed)
- That do not meet the above the inclusion criteria;
- Advanced critical cases, the expected survival is less than 3 months;
- The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
- The submandibular gland pathological changes;
- During radiotherapy taking other drugs in patients with treatment of stomatitis;
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 |
|---|---|---|
| ChiNing decoctionAlso: Addition and subtraction of Liangge SanChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People. | Drug | ChiNing decoction |
Primary outcome
Grading standard of RTOG in acute radiation injury of oral mucosal
Time frame: 8 days
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
4 secondary outcomes
The visual analogue scale of oral pain
Time frame: 8 days
EORTCQLQ-H&N35
Time frame: 8 days
patient body weight changes
Time frame: 8 days
Safety index
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Background: PubMed 20921827Ryu SH, Kang KM, Moon SY, Chai GY, Hong JP, Cho KO, Kang MI, Choi EK, Lee SW. Therapeutic effects of recombinant human epidermal growth factor (rhEGF) in a murine model of concurrent chemo- and radiotherapy-induced oral mucositis. J Radiat Res. 2010;51(5):595-601. doi: 10.1269/jrr.10069.
- Background: PubMed 16258486Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.
- Background: PubMed 22679734Wang B, Cao SH, Wang YQ. [Effects of modified liangge powder contained serum on LPS stimulated TLR4 expression and release of cytokines in mouse platelets]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 May;32(5):681-4. Chinese.
- Background: PubMed 16573003Yu LZ, Jiang AD, Cheng YY, Lin H, Qin QH, Ma XD. [Liangge san effects the expression of CD14 and scaverger receptor in the Kupffer cells of liver of endotoxemia mice]. Zhongguo Zhong Yao Za Zhi. 2006 Feb;31(3):220-3. Chinese.
- Background: PubMed 15958292Jiang AD, Yu LZ, Gong XW, Deng P, Ma XD. [Effect of Liangge San on lipopolysaccharide-induced nuclear factor kappa B activation in cultured mouse macrophages]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Jun;25(6):619-22. Chinese.
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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.
Cong Wang, Master principal investigator
National Clinical Research Center for Cancer of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ChiNing decoction in people with Head and Neck Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 22 Dec 2015. 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 China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading standard of RTOG in acute radiation injury of oral mucosal (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303197, which also lists 5 linked publications.
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 Dec 2015.