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

NCT ID: NCT05008471

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2022-04-26

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.

Conditions

Nasopharyngeal Carcinoma; Radiation Therapy Induced Change; Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

The recommended target energy for NPC radiotherapy patients is 25-30kcal/(kg·d), in addition，the intervention group begins with an additional 50% daily energy increase during the peri-radiotherapy.

Group Type: EXPERIMENTAL

Formula nutrition

Intervention Type: DIETARY_SUPPLEMENT

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.

Conventional group

Unlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yun-fei Xia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunfei Xia, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunfei Xia, MD

Role: CONTACT

xiayf@sysucc.org.cn

13602805461

Facility Contacts

Yunfei Xia, MD

Role: primary

xiayf@sysucc.org.cn

13602805461

Other Identifiers

2020-FXY-487

Identifier Type: -

Identifier Source: org_study_id