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Status unknownNCT02945878Updated Jun 28, 2017

Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma

An observational study in Nasopharyngeal Neoplasms and Stomatitis, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Zhejiang Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.

02

Conditions studied

  • Nasopharyngeal Neoplasms
  • Stomatitis

Keywords

  • radiotherapy, oral mucositis,oral mucosa protection
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In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's planned enrollment of 90 is below the median of 300 across 135 observational studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Histologically conformed Initial nasopharyngeal carcinoma

Inclusion criteria

  1. Histologically conformed Initial nasopharyngeal carcinoma
  2. Patients can feed through the mouth.
  3. ECOG (Eastern Cooperative Oncology Group) : 0-1.
  4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.
  5. 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).
  6. Informed consent signed.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. gradings of oral mucositis

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02945878
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Oct 26, 2016
Start date
Oct 2016
Primary completion
Mar 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Jun 28, 2017

Study contacts

Yuanyuan Chen, Professor
Contact
chenyy@zjcc.org.cn
+86 13738103808
Shuang Huang, Doctor
Contact
hnhuangshuang525@163.com
+86 18069801225
Yuanyuan Chen, Professor
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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