Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 388
- Locations
- 1
- Primary Endpoint
- Incidence of acute radiation reactions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with nasopharyngeal carcinoma confirmed by histopathology
- •Newly diagnosed patients without distant metastasis
- •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.
Arms & Interventions
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.
Intervention: Formula nutrition (Dietary Supplement)
Conventional group
Unlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.
Outcomes
Primary Outcomes
Incidence of acute radiation reactions
Time Frame: 12 months
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.
Secondary Outcomes
- Incidence of decline in nutritional status(12 months)
- Incidence of decline in quality of life scores（QOL）(12 months)
- Self-rating Anxiety screening Scale（GAD-7)(12 months)
- Self-rating Scale for Depression Screening (PHQ-9)(12 months)
Investigators
Yun-fei Xia
Principal Investigator
Sun Yat-sen University