Clinical trial NCT05008471: Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Radiation Therapy Induced Change
Nutrition Disorders
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Second Affiliated Hospital, Sun Yat-Sen University
First posted: 2021-08-17
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute radiation reactions
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of decline in nutritional status
timeFrame: 12 months
measure: Incidence of decline in quality of life scores（QOL）
timeFrame: 12 months
measure: Self-rating Anxiety screening Scale（GAD-7)
timeFrame: 12 months
measure: Self-rating Scale for Depression Screening (PHQ-9)
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Xia, MD
role: PRINCIPAL_INVESTIGATOR
References: