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

NCT05008471 | Unknown DMC

• 1 other identifier: 2020-FXY-487
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Radiation Therapy Induced Change; Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

• Incidence of acute radiation reactions

  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.

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Formula nutrition

Conventional group

NO INTERVENTION

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

Interventions

Formula nutrition 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, 510000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nutrition Disorders

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yunfei Xia, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunfei Xia, MD

CONTACT

13602805461; xiayf@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 17, 2021
• Study Start: April 26, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

CN (1)