Nasopharyngeal CarcinomaPhase 3NCT03720340
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis
A Phase 3 study testing Recombinant Human Interleukin-11 and Saline in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Recombinant Human Interleukin-11 and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Aug 2022
- 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
- Clinical diagnosis of nasopharyngeal carcinoma.
- 8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
- Age must beetween 18-75.
- Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
- Adequate bone marrow, renal, and hepatic function.
Who cannot join
- chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
- Treatment with palliative intent.;Previous malignancy.
- Pregnancy or lactation.
- A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
- Diabetes, oral mucositis and senile dry stomatitis.
- Any severe coexisting disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yuanyuan Chen, Professor, +86 13738103808, chenyy@zjcc.org.cn
About this study
Official title: The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.
Read the detailed description
All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. Oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. Patients were randomly divided into two groups randomly. IL-11 was used in experience group and control group, saline.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Recombinant Human Interleukin-11, Saline
- Keywords
- Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interleukin-11Drug
Recombinant Human Interleukin-11 was administed through respiratory tract.
SalineDrug
saline was administed through respiratory tract
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human interleukin-11 | Active comparator | Mixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract. Receives: Drug: Recombinant Human Interleukin-11; Drug: Saline |
| Saline | Placebo comparator | Only 10ml 0.9% NS was administered twicely to patients through respiratory tract. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe acute radioactive oral mucitis
Radiation Therapy Oncology Group/European Organization for research and treatment acute radiation morbidity scoring criteria. Grade 0: No change over baseline, Grade 1: Injection/ may experience mild pain not requiring analgesic, Grade 2: Patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, Grade 3: Confluent fibrinous mucositis/ may include severe pain requiring narcotic, Grade 4: Ulceration, hemorrhage or necrosis, Grade 5: death (Higher score equals to worse outcome).
Measured: through study completion, an average of 5mouth
Secondary outcomes (6)
Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups
RGOT/ CTCA
Measured: first day from radiation to the date 3 degree acute radioactive oral mucitis occurred
last period of severe acute radioactive oral mucitis
RGOT/ CTCA
Measured: through study completion, an average of 5month
Changes in oral flora
Changes in oral flora during treatments
Measured: through study completion, an average of 5month
Changes in intestinal flora
Changes in oral intestinal during treatments
Measured: through study completion, an average of 5month
Nutritional status
Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients
Measured: through study completion, an average of 5month
Comparison of quality of life
Life Quality Measurement Scale H\&N35 Comparison of quality of life between two groups of patients
Measured: through study completion, an average of 5month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen yuanyuan, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720340
- Sponsor's protocol ID
- IRB-2018-180
- Status last verified
- Aug 2020
- First submitted
- 10 Oct 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
- ClinicalTrials.gov ID
- NCT03720340
- Acronym / sponsor ID
- IRB-2018-180
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 25 Oct 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.
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.
Detailed description
All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. Oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. Patients were randomly divided into two groups randomly. IL-11 was used in experience group and control group, saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant human interleukin-11 | Active comparator | Drug: Recombinant Human Interleukin-11, Drug: SalineMixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract. |
| Saline | Placebo comparator | Drug: SalineOnly 10ml 0.9% NS was administered twicely to patients through respiratory tract. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of nasopharyngeal carcinoma.
- 8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
- Age must beetween 18-75.
- Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
- Adequate bone marrow, renal, and hepatic function.
Key exclusion criteria (6 listed)
- chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
- Treatment with palliative intent.;Previous malignancy.
- Pregnancy or lactation.
- A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
- Diabetes, oral mucositis and senile dry 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 |
|---|---|---|
| Recombinant Human Interleukin-11Recombinant Human Interleukin-11 was administed through respiratory tract. | Drug | Recombinant human interleukin-11 |
| Salinesaline was administed through respiratory tract | Drug | Recombinant human interleukin-11, Saline |
Primary outcome
Incidence of severe acute radioactive oral mucitis
Time frame: through study completion, an average of 5mouth
Radiation Therapy Oncology Group/European Organization for research and treatment acute radiation morbidity scoring criteria. Grade 0: No change over baseline, Grade 1: Injection/ may experience mild pain not requiring analgesic, Grade 2: Patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, Grade 3: Confluent fibrinous mucositis/ may include severe pain requiring narcotic, Grade 4: Ulceration, hemorrhage or necrosis, Grade 5: death (Higher score equals to worse outcome).
6 secondary outcomes
Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups
Time frame: first day from radiation to the date 3 degree acute radioactive oral mucitis occurred
last period of severe acute radioactive oral mucitis
Time frame: through study completion, an average of 5month
Changes in oral flora
Time frame: through study completion, an average of 5month
Changes in intestinal flora
Time frame: through study completion, an average of 5month
Nutritional status
Time frame: through study completion, an average of 5month
Comparison of quality of life
Time frame: through study completion, an average of 5month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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 3 study testing Recombinant Human Interleukin-11 and Saline in people with Nasopharyngeal Carcinoma, run by Zhejiang 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 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe acute radioactive oral mucitis (time frame: through study completion, an average of 5mouth). 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 11 Aug 2020.