Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy
NCT ID: NCT04810936
Last Updated: 2021-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
272 participants
INTERVENTIONAL
2019-07-26
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Early ONS intervention group
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.
oral nutritional supplements
Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.
Standard nutrition intervention group
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).
No interventions assigned to this group
Interventions
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oral nutritional supplements
Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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YI PAN
Prof.
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GDREC2018296H(R1)
Identifier Type: -
Identifier Source: org_study_id
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