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

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Dietary Supplement: Healing Elements,Methuselah Medical Technology

• Registration Number: NCT02776124
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Primary Completion: 2016-08
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONS group	Healing Elements,Methuselah Medical Technology	Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)

Primary Outcome Measures

Name	Time	Method
Body weight(kg)change during concurrent chemotherapy	every week during the course of radiotherapy, up to 6-7 weeks

Secondary Outcome Measures

Name	Time	Method
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
Fat 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
Skeletal muscle 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.
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
Serum transferrins（mg/dL）change	every 2 weeks 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
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

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China