Clinical trial NCT04810936: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
malnutrition
Early nutritional intervention
chemoradiotherapy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The percentage of patients who lose >5% of initial body weight
timeFrame: 7 weeks
Secondary outcomes:
measure: Weight loss at the last day of radiotherapy
timeFrame: 7 weeks
measure: Weight loss at the end of 4th week
timeFrame: 11 weeks
measure: 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
timeFrame: 11 weeks
measure: Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy
timeFrame: 7 weeks
measure: Incidence of any grade 3-4 side-effect (CTCAE 4.03).
timeFrame: 7 weeks
measure: Incidence of prolonged radiation treatment time caused by side-effects
timeFrame: 7 weeks
measure: Days prolonged more than planed treatment time caused by side-effects
timeFrame: 7 weeks
measure: Incidence of unplanned hospitalization in 3 months after radiation
timeFrame: 5 months
measure: 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
timeFrame: 5 months
measure: The treatment time of parenteral nutrition (PN) treatment
timeFrame: 5 months
measure: 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
timeFrame: 5 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: