Nasopharyngeal NeoplasmsNCT02945878
Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Neoplasms and Stomatitis, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Stomatitis
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically conformed Initial nasopharyngeal carcinoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yuanyuan Chen, Professor, +86 13738103808, chenyy@zjcc.org.cn
About this study
Official title: Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma
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.
- Conditions
- Nasopharyngeal Neoplasms, Stomatitis
- Keywords
- radiotherapy, oral mucositis,oral mucosa protection
- Medical subject headings
- Nasopharyngeal Neoplasms, Stomatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
gradings of oral mucositis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanyuan Chen, Professor, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945878
- Sponsor's protocol ID
- NPC-MUCO
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02945878
- Acronym / sponsor ID
- NPC-MUCO
- Conditions
- Nasopharyngeal Neoplasms, Stomatitis
- Keywords
- radiotherapy, oral mucositis,oral mucosa protection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically conformed Initial nasopharyngeal carcinoma
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gradings of oral mucositis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanyuan Chen, Professor principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Neoplasms and Stomatitis, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Chen, Professor (+86 13738103808, chenyy@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gradings of oral mucositis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.