NCT02945878

Brief Summary

This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

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, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 28, 2017

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

October 25, 2016

Last Update Submit

June 27, 2017

Conditions

Nasopharyngeal NeoplasmsStomatitis

Keywords

radiotherapy, oral mucositis,oral mucosa protection

Outcome Measures

Primary Outcomes (1)

  • gradings of oral mucositis

    3 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically conformed Initial nasopharyngeal carcinoma

You may qualify if:

  • Histologically conformed Initial nasopharyngeal carcinoma
  • Patients can feed through the mouth.
  • ECOG (Eastern Cooperative Oncology Group) : 0-1.
  • No history of chemo-radiotherapy, immuno-therapy or biotherapy.
  • Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
  • Informed consent signed.

You may not qualify if:

  • History of malignant tumors.
  • Any severe complications contraindicated chemotherapy or radiotherapy.
  • Medical history of central nervous system, cognitive or psychological diseases;
  • Pregnant or nursing women.
  • Patients with mental disease cannot complete the questionaire.
  • Patients refused the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsStomatitis

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth Diseases

Study Officials

  • Yuanyuan Chen, Professor

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanyuan Chen, Professor

CONTACT

+86 13738103808chenyy@zjcc.org.cn

Shuang Huang, Doctor

CONTACT

+86 18069801225hnhuangshuang525@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

June 28, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)