Clinical trial NCT02776124: Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nutritional status
nasopharyngeal carcinoma
Nutritional Counseling
concurrent chemoradiotherapy
oral nutritional supplements
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2016-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight(kg)change during concurrent chemotherapy
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
Secondary outcomes:
measure: Disease-free survival
timeFrame: 2 years
measure: 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
timeFrame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
timeFrame: every week during the course of radiotherapy, up to 6-7 weeks
measure: Serum albumin（g/L) change
timeFrame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
measure: Serum prealbumin（mg/dL) change
timeFrame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
measure: Serum transferrins（mg/dL）change
timeFrame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
References: