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

NCT ID: NCT02945878

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nasopharyngeal Neoplasms Stomatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuanyuan Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanyuan Chen, Professor

Role: CONTACT

+86 13738103808

Shuang Huang, Doctor

Role: CONTACT

+86 18069801225

Facility Contacts

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Yuanyuan Chen, Professor

Role: primary

+86 13738103808

Other Identifiers

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NPC-MUCO

Identifier Type: -

Identifier Source: org_study_id

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