NCT03720340

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

October 10, 2018

Last Update Submit

August 10, 2020

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaAcute Radiation Oral MucositisRecombinant human interleukin-11oral microflora

Outcome Measures

Primary Outcomes (1)

  • 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).

    through study completion, an average of 5mouth

Secondary Outcomes (6)

  • Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups

    first day from radiation to the date 3 degree acute radioactive oral mucitis occurred

  • last period of severe acute radioactive oral mucitis

    through study completion, an average of 5month

  • Changes in oral flora

    through study completion, an average of 5month

  • Changes in intestinal flora

    through study completion, an average of 5month

  • Nutritional status

    through study completion, an average of 5month

  • +1 more secondary outcomes

Study Arms (2)

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.

Drug: Recombinant Human Interleukin-11Drug: Saline

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Recombinant Human Interleukin-11DRUG

Recombinant Human Interleukin-11 was administed through respiratory tract.

Recombinant human interleukin-11
SalineDRUG

saline was administed through respiratory tract

Recombinant human interleukin-11Saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of nasopharyngeal carcinoma.
  • th 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Interleukin-11Sodium Chloride

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 25, 2018

Study Start

October 1, 2018

Primary Completion

August 31, 2021

Study Completion

August 30, 2022

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)