Brief Title
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Body weight(kg)change during concurrent chemotherapy
Secondary Outcome
Disease-free survival
Condition
Nasopharyngeal Carcinoma
Intervention
Healing Elements,Methuselah Medical Technology
Study Arms / Comparison Groups
ONS group
Description: Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
60
Start Date
June 2014
Completion Date
January 2018
Primary Completion Date
August 2016
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02776124
Organization ID
1405135-4
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Fudan University
Study Sponsor
, ,
Verification Date
March 2018