Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.

Official Title
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A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Dietary Supplement: Healing Elements,Methuselah Medical Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV） Concurrent radiation and chemotherapy(platinum ) Karnofsky score over 60 No evidence of metastatic disease No significant cardiac, chest, gastrointestinal or renal morbidities Exclusion Criteria: age <18 years ongoing artificial nutrition refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONS group<br>Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements) | Dietary Supplement: Healing Elements,Methuselah Medical Technology<br>* ONS group will receive Healing Elements ONS everyday during CRT<br>|
| No Intervention: control group<br>Individualized dietary counseling during CRT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight(kg)change during concurrent chemotherapy |  | every week during the course of radiotherapy, up to 6-7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years. | 2 years | 
| Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment | participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks | every 2 weeks during the course of radiotherapy, up to 6-7 weeks | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis |  | every week during the course of radiotherapy, up to 6-7 weeks | 
| Serum albumin（g/L) change |  | every 2 weeks during the course of radiotherapy, up to 6-7 weeks | 
| Serum prealbumin（mg/dL) change |  | every 2 weeks during the course of radiotherapy, up to 6-7 weeks | 
| Serum transferrins（mg/dL）change |  | every 2 weeks during the course of radiotherapy, up to 6-7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements