NCT04810936

Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition
• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral nutritional supplements	Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.

Timeline

• Start date: 2019-07-26
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-03-23
• Last updated: 2021-03-23

Locations

1 site across 1 country: China