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

Sun Yat-sen University

Status: Unknown

Conditions: Nutrition Disorders; Nasopharyngeal Carcinoma; Radiation Therapy Induced Change

Treatments: Dietary Supplement: Formula nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05008471

2020-FXY-487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Formula nutrition

Conventional group

No Intervention group

Description:

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