Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

NCT04810936 | Unknown

• 1 other identifier: GDREC2018296H(R1)
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; malnutrition; Early nutritional intervention; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 %.

  7 weeks

Secondary Outcomes (11)

• Weight loss at the last day of radiotherapy

  7 weeks

• Weight loss at the end of 4th week

  11 weeks

• 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

  11 weeks

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

  7 weeks

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

  7 weeks

Study Arms (2)

Early ONS intervention group

EXPERIMENTAL

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.

Dietary Supplement: oral nutritional supplements

Standard nutrition intervention group

NO INTERVENTION

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).

Interventions

oral nutritional supplements DIETARY_SUPPLEMENT

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

Early ONS intervention group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Malnutrition; Nasopharyngeal Carcinoma

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; 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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Yi Pan, Prof.

CONTACT

+86020-83827812; panyiff01@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 23, 2021
• Study Start: July 26, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)