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Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03647527
Recruitment Status : Unknown
Verified August 2018 by Chen yuanyuan, Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Information provided by (Responsible Party):
Chen yuanyuan, Zhejiang Cancer Hospital

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, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.

Condition or disease
Nasopharyngeal Carcinoma

Detailed Description:
To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. the highest grade of oral mucositis [ Time Frame: oral mucocitis will be checked every day during the date of initiation of radiation therapy until the date of completion of radiation therapy, the highest grade ≥ 3 define as severe oral mubocitis, assessed up to a month and a half ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Between September 2016 and August 2018, consecutive patients with II-IVB nasopharyngeal carcinoma receiving intensity modulated radiotherapy or tomography radiotherapy.

Inclusion Criteria:

1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 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. Treatment with palliative intent.
  2. Previous malignancy.
  3. Pregnancy or lactation.
  4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
  5. Any severe coexisting disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03647527

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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: yuanyuan chen, Professor    +86 13738103808   
Sponsors and Collaborators
Zhejiang Cancer Hospital
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Principal Investigator: Yuanyuan Chen Zhejiang Cancer Hospital
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Responsible Party: Chen yuanyuan, Clinical Professor, Zhejiang Cancer Hospital Identifier: NCT03647527    
Other Study ID Numbers: PF-AROM-NPC-IMRT/TOMO
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chen yuanyuan, Zhejiang Cancer Hospital:
nasopharyngeal carcinoma
acute radiation oral mucositis
intensity modulated radiotherapy
tomography radiotherapy
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases