Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients
Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study
1 other identifier
observational
186
1 country
1
Brief Summary
This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 30, 2020
July 1, 2020
4.6 years
September 19, 2015
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body weight
baseline and 36 months
Secondary Outcomes (9)
Acute Toxicity
3 months
Number of Participants With Abnormal Laboratory Values
36 months
Adverse Events That Are Related to Treatment
36 months
Tumor regressive rate after treatment
36 months
Late toxicity
36 months
- +4 more secondary outcomes
Study Arms (1)
NC+CCRT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)
Interventions
NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses. CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT). Dietary supplement: enteral nutrition and parenteral nutrition
Eligibility Criteria
III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic diagnosis of World Health Organization(WHO) II
You may qualify if:
- Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II)
- All genders，range from 18～65 years old
- Karnofsky performance status(KPS) ≥ 80
- Clinical stage III\~IVb(UICC 7th)
- Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
- Without significant cardiac，respiratory，kidney or liver disease
- Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
- white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
- alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
- Inform consent form
You may not qualify if:
- Distance metastases
- Second malignancy within 5 years
- Drug or alcohol addition
- Do not have full capacity for civil acts
- Active systemic infections
- Chronic consumptions
- Mental disorder
- Pregnancy or lactation
- Concurrent immunotherapy or hormone therapy for other diseases
- Severe complication, eg, uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhao Chonglead
- Wuhan Universitycollaborator
- Fudan Universitycollaborator
- Fujian Cancer Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
- Cancer Hospital of Guizhou Provincecollaborator
- Hainan People's Hospitalcollaborator
- First People's Hospital of Foshancollaborator
Study Sites (1)
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Related Publications (1)
Miao J, Wang L, Ong EHW, Hu C, Lin S, Chen X, Chen Y, Zhong Y, Jin F, Lin Q, Lin S, Hu X, Zhang N, Wang R, Wang C, Guo X, Yit NLF, Shi H, Tan SH, Mai H, Xie C, Chua MLK, Zhao C. Effects of induction chemotherapy on nutrition status in locally advanced nasopharyngeal carcinoma: a multicentre prospective study. J Cachexia Sarcopenia Muscle. 2023 Apr;14(2):815-825. doi: 10.1002/jcsm.13196. Epub 2023 Mar 5.
PMID: 36872457DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong Zhao, M.D
Sun Yat-sen University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 19, 2015
First Posted
October 14, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2020
Study Completion
June 1, 2020
Last Updated
July 30, 2020
Record last verified: 2020-07