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Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Interleukin-11
Saline
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Clinical diagnosis of nasopharyngeal carcinoma.
  2. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
  3. Age must beetween 18-75.
  4. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
  5. Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

  1. chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
  2. Treatment with palliative intent.;Previous malignancy.
  3. Pregnancy or lactation.
  4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
  5. Diabetes, oral mucositis and senile dry stomatitis.
  6. Any severe coexisting disease.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Recombinant human interleukin-11

Saline

Arm Description

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.

Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups
RGOT/ CTCA
last period of severe acute radioactive oral mucitis
RGOT/ CTCA
Changes in oral flora
Changes in oral flora during treatments
Changes in intestinal flora
Changes in oral intestinal during treatments
Nutritional status
Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients
Comparison of quality of life
Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients

Full Information

First Posted
October 10, 2018
Last Updated
August 10, 2020
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03720340
Brief Title
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis
Official Title
The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant human interleukin-11
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interleukin-11
Intervention Description
Recombinant Human Interleukin-11 was administed through respiratory tract.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
saline was administed through respiratory tract
Primary Outcome Measure Information:
Title
Incidence of severe acute radioactive oral mucitis
Description
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).
Time Frame
through study completion, an average of 5mouth
Secondary Outcome Measure Information:
Title
Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups
Description
RGOT/ CTCA
Time Frame
first day from radiation to the date 3 degree acute radioactive oral mucitis occurred
Title
last period of severe acute radioactive oral mucitis
Description
RGOT/ CTCA
Time Frame
through study completion, an average of 5month
Title
Changes in oral flora
Description
Changes in oral flora during treatments
Time Frame
through study completion, an average of 5month
Title
Changes in intestinal flora
Description
Changes in oral intestinal during treatments
Time Frame
through study completion, an average of 5month
Title
Nutritional status
Description
Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients
Time Frame
through study completion, an average of 5month
Title
Comparison of quality of life
Description
Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients
Time Frame
through study completion, an average of 5month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Chen, Professor
Phone
+86 13738103808
Email
chenyy@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

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