Radiation Induced Oral MucositisNCT03518489
Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer
A study testing Lappaconitine Adhesive Patch in people with Radiation Induced Oral Mucositis, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation Induced Oral Mucositis
- What is being tested?
- Lappaconitine Adhesive Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Jan 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
- Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
- Karnofsky Performance Status Scale between 60-100
- WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
- ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- Sign the informed consent.
Who cannot join
- Younger than 18 years old or older than 70 years old
- Pregnancy or lactation
- Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- Have suffered from other tumor or now suffering from other tumor
- Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
- Refuse to give up smoking/drinking/betel chewing
- suffering from other active infection diseases and in need of treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Cancer Hospital Radiation Oncology Department
Fuzhou, Fujian, 350014
wu zhuang, master, 0086-02083660063, fjthkjk@sohu.com
About this study
Official title: Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer ： A Randomized, Prospective Single-center Controlled Study
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.
Read the detailed description
This is a randomized, single -center study conducted in China to evaluate Lappaconitine Adhesive Patch in the reduction severity of radiation induced oral mucositis pain in patients receiving solo radiation therapy or chemoradiation therapy for nasopharyngeal carcinoma.
Patients will reveive daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Patients in both arms received Intensity Modulated Radiation Therapy(IMRT) :All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose is 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions.
Patients will be randomized equally to 1 of 2 treatment arms:
Arm A: Lappaconitine Adhesive Patch per day, concurrent with stardard care for oral mucositis Arm B: stardard care for oral mucositis
All patients will be assessed weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 7 weeks, or until oral mucositis resolves to ≤ Grade 1.
Approximately 200 patients will be enrolled to ensure that roughly 80 patients per arm complete treatments for primary endpoint analysis.
- Conditions
- Radiation Induced Oral Mucositis
- Being tested
- Lappaconitine Adhesive Patch, standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lappaconitine Adhesive PatchDrug
Also called standard care
to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain
standard careDrug
Standard care will include mouth wash with antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy. Receives: Drug: Lappaconitine Adhesive Patch |
| Control | Active comparator | Patients will be given standard care when oral pain is reported Receives: Drug: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks
The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded.
Measured: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
Secondary outcomes (4)
Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2)
The Oral Mucositis Score of World Health Organization (WHO) was classified based on the changes of patients' oral mucosa and ability to eat, and are classified to 4 grades. WHO scale for oral mucositis (available in: Peterson DE, Boersdoets CB, Bensadoun RJ, et al. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Annals of Oncology 2015; 26(supply5). https://doi.org/10.1093/annonc/mdv202 ): Grade 0 = no oral mucositis; Grade 1 = erythema and soreness; Grade 2 = ulcers, able to eat solids; Grade 3 = ulcers, requires liquid diet (due to mucositis); Grade 4 = ulcers, alimentation not possible (due to mucositis).
Measured: The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Quality of Life at 7 weeks
he quality of life for all participants was evaluated according to The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (available in: Grønvold M. EORTC QLQ-C30 Scoring Manual 2014.)
Measured: The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Karnofsky Performance Status Scale at 7 weeks
The functional status for all participants was assessed according to Karnofsky Performance Status Scale (KPS Scale) (available in: Friendlander AH, Ettinger RL. Karnofsky performance status scale[J]. Special Care in Dentistry, 2009, 29(4):147.). The KPS Scale was range from 0 to 100, and were averagely divided into eleven grades begin with 0.
Measured: The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
The Adverse events Related to lappaconitine
The adverse events related to lappaconitine based on medicine specification of lappaconitine was observed and recorded down according to Common toxicity criteria, version 2.0. (available in: Version CTC, Version CTC, Date P, et al. Common toxicity criteria (ctc) 1999.)
Measured: The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Induced Oral MucositisStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shufang Qiu, M.D., Study director, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518489
- Sponsor's protocol ID
- FujianCH
- Status last verified
- May 2018
- First submitted
- 23 Apr 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer ： A Randomized, Prospective Single-center Controlled Study
- ClinicalTrials.gov ID
- NCT03518489
- Acronym / sponsor ID
- FujianCH
- Conditions
- Radiation Induced Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 8 May 2018 (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 purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.
Detailed description
This is a randomized, single -center study conducted in China to evaluate Lappaconitine Adhesive Patch in the reduction severity of radiation induced oral mucositis pain in patients receiving solo radiation therapy or chemoradiation therapy for nasopharyngeal carcinoma.
Patients will reveive daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Patients in both arms received Intensity Modulated Radiation Therapy(IMRT) :All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose is 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions.
Patients will be randomized equally to 1 of 2 treatment arms:
Arm A: Lappaconitine Adhesive Patch per day, concurrent with stardard care for oral mucositis Arm B: stardard care for oral mucositis
All patients will be assessed weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 7 weeks, or until oral mucositis resolves to ≤ Grade 1.
Approximately 200 patients will be enrolled to ensure that roughly 80 patients per arm complete treatments for primary endpoint analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Lappaconitine Adhesive PatchLappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy. |
| Control | Active comparator | Drug: standard carePatients will be given standard care when oral pain is reported |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
- Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
- Karnofsky Performance Status Scale between 60-100
- WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
- ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
Key exclusion criteria (7 listed)
- Younger than 18 years old or older than 70 years old
- Pregnancy or lactation
- Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- Have suffered from other tumor or now suffering from other tumor
- Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
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 |
|---|---|---|
| Lappaconitine Adhesive PatchAlso: standard careto evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain | Drug | Experimental |
| standard careStandard care will include mouth wash with antibiotics. | Drug | Control |
Primary outcome
Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks
Time frame: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded.
4 secondary outcomes
Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2)
Time frame: The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Quality of Life at 7 weeks
Time frame: The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Karnofsky Performance Status Scale at 7 weeks
Time frame: The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
The Adverse events Related to lappaconitine
Time frame: The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
Shufang Qiu, M.D. study director
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lappaconitine Adhesive Patch in people with Radiation Induced Oral Mucositis, run by Fujian Cancer 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 6 inclusion and 7 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 14 May 2018. 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.
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 Jing Huang, master (13375001112, huangjing2567@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks (time frame: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 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 14 May 2018.