Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

August 10, 2020 updated by: Chen yuanyuan, Zhejiang Cancer Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Recombinant human interleukin-11
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.
Drug: Recombinant Human Interleukin-11
Recombinant Human Interleukin-11 was administed through respiratory tract.
Drug: Saline
saline was administed through respiratory tract
Placebo Comparator: Saline
Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
Drug: Saline
saline was administed through respiratory tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 5mouth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
RGOT/ CTCA
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
RGOT/ CTCA
through study completion, an average of 5month
Changes in oral flora
Time Frame: through study completion, an average of 5month
Changes in oral flora during treatments
through study completion, an average of 5month
Changes in intestinal flora
Time Frame: through study completion, an average of 5month
Changes in oral intestinal during treatments
through study completion, an average of 5month
Nutritional status
Time Frame: through study completion, an average of 5month
Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients
through study completion, an average of 5month
Comparison of quality of life
Time Frame: through study completion, an average of 5month
Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients
through study completion, an average of 5month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2018-180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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