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

Last updated: August 14, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasopharyngeal Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05008471
2020-FXY-487
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bereceived, andIMRT was used for radiotherapy
  • The patient's blood counts,the lung, liver and renal functions were tolerant toradiotherapy/chemoradiotherapy( WBC ≥ 4.0109/L, NE ≥ 2.0109/L, PLT 100109/L and Hb≥ 10g/L. AST and ALT ≤ 2.5 the upper limit(UL) ,TBIL≤1.2the UL, CRE≤1.2 the UL, andALP≤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 situskin 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

Exclusion Criteria:

  • Patients with gastrointestinal dysfunction, intestinal obstruction, pyloricobstruction, 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 positivepregnancy test before receiving treatment
  • Special dietary requirements: such as no having a certain food or a vegetarian.

Study Design

Total Participants: 388
Study Start date:
April 26, 2021
Estimated Completion Date:
April 26, 2022

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou 510000
    China

    Active - Recruiting

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