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

Primary Purpose

Nasopharyngeal Carcinoma, Radiation Therapy Induced Change, Nutrition Disorders

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Formula nutrition

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Conventional group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of decline in nutritional status

analysis by the clinical nutrition detection analyzer

Incidence of decline in quality of life scores（QOL）

It is measured by a standard QOL table,including 12 questions.Each question is 5 points,so there are 60 points and 5 grades(51-60 points, 41-50 points, 31-40 points, 21-30 points,<20 points).A higher score is a better life.

Self-rating Anxiety screening Scale（GAD-7)

A GAD-7 table would estimate one's anxiety according to the emotion of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of anxiety, a LOWER score means a normal mind state. Actually,0-4 points is/are no anxiety.5-9 points represent slight anxiety .10-14 are in moderate anxiety.15-27 are severe anxiety,respectively.

Self-rating Scale for Depression Screening (PHQ-9)

A PHQ-9 table is a simplified Scale for Depression Screening,it would estimate one's depression emotion according to the mind of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of depression, a LOWER score is equal to a GOOD mind.Actually,0-4 points is/are no depression.5-9 are depressed but not obvious.10-14 are in obvious depression.15-27 are severe depression,respectively.

Full Information

NCT ID

NCT05008471

First Posted

August 3, 2021

Last Updated

August 14, 2021

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT05008471

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2021 (Actual)

Primary Completion Date

April 26, 2022 (Anticipated)

Study Completion Date

April 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Radiation Therapy Induced Change, Nutrition Disorders

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Arm Title

Conventional group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Formula nutrition

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of acute radiation reactions

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Incidence of decline in nutritional status

Description

analysis by the clinical nutrition detection analyzer

Time Frame

12 months

Title

Incidence of decline in quality of life scores（QOL）

Description

Time Frame

12 months

Title

Self-rating Anxiety screening Scale（GAD-7)

Description

Time Frame

12 months

Title

Self-rating Scale for Depression Screening (PHQ-9)

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunfei Xia, MD

Phone

13602805461

xiayf@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yunfei Xia, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangdong

State/Province

Guangzhou

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunfei Xia, MD

Phone

13602805461

xiayf@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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