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Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

Primary Purpose

Malnutrition, Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

oral nutritional supplements

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Nasopharyngeal carcinoma, malnutrition, Early nutritional intervention, chemoradiotherapy

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed nasopharyngeal carcinoma (NPC).
The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
Age ≥ 18 years and < 75 years.
Performance status (PS) score 0-1.
NRS2002<3 .
Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L
Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value, bilirubin < 1.2 times the upper limit of normal value, creatinine < 1.2 times the upper limit of normal value, and alkaline phosphatase < 5 times the upper limit of normal value.
Could complete required oral nutrition, questionnaire survey and follow-up.
Signed informed consent voluntarily.

Exclusion Criteria:

Had a history of head and neck radiotherapy.
Known allergic reaction to any component of ONS, or severe allergic constitution.
With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
Pregnancy and lactation.
Other conditions that the investigators consider as inappropriate for enrolling into this study.
Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.

Sites / Locations

Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early ONS intervention group

Standard nutrition intervention group

Arm Description

Patients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day.

Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy).

Outcomes

Primary Outcome Measures

The percentage of patients who lose >5% of initial body weight

Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy *100 %.

Secondary Outcome Measures

Weight loss at the last day of radiotherapy

The changes of weight at the last day of radiotherapy

Weight loss at the end of 4th week

The changes of weight at the end of 4th week

Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy

PG-SGA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy

Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy

Incidence of radiation induced grade 3-4 mucositis at the end of 4th week and the last day of radiotherapy

Incidence of any grade 3-4 side-effect (CTCAE 4.03).

Incidence of any grade 3-4 side-effect induced by radiotherapy or chemotherapy during chemoradiotherapy

Incidence of prolonged radiation treatment time caused by side-effects

Incidence of prolonged radiation treatment time caused by chemoradiation related side-effects. Prolonged radiation treatment time is defined as the overall treatment time is longer than plan

Days prolonged more than planed treatment time caused by side-effects

Days prolonged more than planed treatment time caused by chemoradiation related side-effects

Incidence of unplanned hospitalization in 3 months after radiation

Incidence of unplanned hospitalization in 3 months after radiation. Unplanned hospitalization is defined as hospitalization caused by chemoradiotherapy related side effects

The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

The treatment time of parenteral nutrition (PN) treatment

PN should be started if enteral nutrition (EN) is anticipated (60% of estimated energy expenditure) for more than 10 days. The treatment time of PN should be recorded

The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Full Information

NCT ID

NCT04810936

First Posted

March 14, 2021

Last Updated

March 19, 2021

Sponsor

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04810936

Brief Title

Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

Official Title

A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 26, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.

Detailed Description

Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy. Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy. This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.

6. Conditions and Keywords

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

Malnutrition, Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, malnutrition, Early nutritional intervention, chemoradiotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early ONS intervention group

Arm Type

Experimental

Arm Description

Arm Title

Standard nutrition intervention group

Arm Type

No Intervention

Arm Description

Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy).

Intervention Type

Dietary Supplement

Intervention Name(s)

oral nutritional supplements

Intervention Description

Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.

Primary Outcome Measure Information:

Title

The percentage of patients who lose >5% of initial body weight

Description

Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy *100 %.

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Weight loss at the last day of radiotherapy

Description

The changes of weight at the last day of radiotherapy

Time Frame

7 weeks

Title

Weight loss at the end of 4th week

Description

The changes of weight at the end of 4th week

Time Frame

11 weeks

Title

Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy

Description

PG-SGA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy

Time Frame

11 weeks

Title

Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy

Description

Incidence of radiation induced grade 3-4 mucositis at the end of 4th week and the last day of radiotherapy

Time Frame

7 weeks

Title

Incidence of any grade 3-4 side-effect (CTCAE 4.03).

Description

Incidence of any grade 3-4 side-effect induced by radiotherapy or chemotherapy during chemoradiotherapy

Time Frame

7 weeks

Title

Incidence of prolonged radiation treatment time caused by side-effects

Description

Incidence of prolonged radiation treatment time caused by chemoradiation related side-effects. Prolonged radiation treatment time is defined as the overall treatment time is longer than plan

Time Frame

7 weeks

Title

Days prolonged more than planed treatment time caused by side-effects

Description

Days prolonged more than planed treatment time caused by chemoradiation related side-effects

Time Frame

7 weeks

Title

Incidence of unplanned hospitalization in 3 months after radiation

Description

Incidence of unplanned hospitalization in 3 months after radiation. Unplanned hospitalization is defined as hospitalization caused by chemoradiotherapy related side effects

Time Frame

5 months

Title

The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Description

The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Time Frame

5 months

Title

The treatment time of parenteral nutrition (PN) treatment

Description

PN should be started if enteral nutrition (EN) is anticipated (60% of estimated energy expenditure) for more than 10 days. The treatment time of PN should be recorded

Time Frame

5 months

Title

The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Description

The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed nasopharyngeal carcinoma (NPC). The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition). Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT). Age ≥ 18 years and < 75 years. Performance status (PS) score 0-1. NRS2002<3 . Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value, bilirubin < 1.2 times the upper limit of normal value, creatinine < 1.2 times the upper limit of normal value, and alkaline phosphatase < 5 times the upper limit of normal value. Could complete required oral nutrition, questionnaire survey and follow-up. Signed informed consent voluntarily. Exclusion Criteria: Had a history of head and neck radiotherapy. Known allergic reaction to any component of ONS, or severe allergic constitution. With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on). Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction). Pregnancy and lactation. Other conditions that the investigators consider as inappropriate for enrolling into this study. Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.

Central Contact Person:

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

Yi Pan, Prof.

Phone

+86020-83827812

panyiff01@163.com

Facility Information:

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Pan, Dr.

Phone

+86-020-83827812

panyiff01@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

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