Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008471
• Other study ID #: 2020-FXY-487
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 26, 2022

Study information

• Verified date: August 2021
• Source: Sun Yat-sen University
• Contact: Yunfei Xia, MD
• Phone: 13602805461
• Email: xiayf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute radiation reaction rate, completion rate of radiotherapy, nutritional status, and quality of life for NPC patients.

Description:

In this study, nutrition intervention was performed in one group of nasopharyngeal carcinoma patients with no nutritional risk during the periperiod of radiotherapy , and the other group with no additional intervention when without nutritional risks, for evaluating the value of overall nutritional management in the periperiod radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with nasopharyngeal carcinoma confirmed by histopathology
• Newly diagnosed patients without distant metastasis
• Age >18
• KPS = 70
• Nasopharyngeal radiotherapy alone or concurrent chemoradiotherapy was planned to be received, andIMRT was used for radiotherapy
• The patient's blood counts,the lung, liver and renal functions were tolerant to radiotherapy/chemoradiotherapy( WBC = 4.0*109/L, NE = 2.0*109/L, PLT 100*109/L and Hb= 10g/L. AST and ALT = 2.5 *the upper limit(UL) ,TBIL=1.2*the UL, CRE=1.2* the UL, and ALP=5* the UL). And the ECG should be normal
• Good nutritional status,BMI:18~23Kg/ m2, PG-SGA =1,NRS 2002<3score
• No other previous neoplastic diseases, except for cured cervical carcinoma in situ skin basal carcinoma
• No serious gastrointestinal diseases (moderate and severe duodenal and gastric ulcer, ulcerative colitis, Crohn's disease, etc.)
• No AIDS and no diabetes
• Clear mind, no communication barriers, able to answer questions
• Voluntarily participate and sign the informed consent in person.

Exclusion Criteria:

• Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction, Acute gastrointestinal bleeding
• Patients who are allergic to nutritional therapy or have severe allergic constitution
• Uncontrolled systemic diseases, such as severe liver disease (such as cirrhosis), kidney disease, respiratory diseases and so on.
• Women who are pregnant or breastfeeding or no contraception and women with positive pregnancy test before receiving treatment
• Special dietary requirements: such as no having a certain food or a vegetarian.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nutrition Disorders

Intervention

Dietary Supplement:
• Formula nutrition
The target energy of radiotherapy patients is recommended to be 25-30kcal/(kg·d), and the target energy of the intervention group should be increased by an additional 50% daily from the beginning of radiotherapy. Specifically, under the condition of ensuring the daily target energy 14kcal/(kg·d), formula nutrition should be added daily.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangdong	Guangzhou

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute radiation reactions	This study mainly includes oral mucosa mucositis, salivary glands injury induced by radiotherapy, laryngoesophageal mucositis referring to The 2020 Expert Consensus on the Standardized Management of Radiation Oncology for nutrition-related radiation injury responses.	12 months
Secondary	Incidence of decline in nutritional status	analysis by the clinical nutrition detection analyzer	12 months
Secondary	Incidence of decline in quality of life scores(QOL)	It is measured by a standard QOL table,including 12 questions.Each question is 5 points,so there are 60 points and 5 grades(51-60 points, 41-50 points, 31-40 points, 21-30 points,<20 points).A higher score is a better life.	12 months
Secondary	Self-rating Anxiety screening Scale(GAD-7)	A GAD-7 table would estimate one's anxiety according to the emotion of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of anxiety, a LOWER score means a normal mind state. Actually,0-4 points is/are no anxiety.5-9 points represent slight anxiety .10-14 are in moderate anxiety.15-27 are severe anxiety,respectively.	12 months
Secondary	Self-rating Scale for Depression Screening (PHQ-9)	A PHQ-9 table is a simplified Scale for Depression Screening,it would estimate one's depression emotion according to the mind of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of depression, a LOWER score is equal to a GOOD mind.Actually,0-4 points is/are no depression.5-9 are depressed but not obvious.10-14 are in obvious depression.15-27 are severe depression,respectively.	12 months