Nasopharyngeal Carcinoma
Conditions
Keywords
Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHealing Elements,Methuselah Medical Technology
ONS group will receive Healing Elements ONS everyday during CRT
Sponsors
Fudan University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV） 2. Concurrent radiation and chemotherapy(platinum ) 3. Karnofsky score over 60 4. No evidence of metastatic disease 5. No significant cardiac, chest, gastrointestinal or renal morbidities
Exclusion criteria
1. age \<18 years 2. ongoing artificial nutrition 3. refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight(kg)change during concurrent chemotherapy | every week during the course of radiotherapy, up to 6-7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | every 2 weeks during the course of radiotherapy, up to 6-7 weeks | participants will be followed for the duration of hospital stay, an expected average of 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 | — |
| Disease-free survival | 2 years | From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years. |
| 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 | — |
| Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis | every week during the course of radiotherapy, up to 6-7 weeks | — |
Countries
China
Outcome results
None listed