- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776124
Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
March 16, 2018 updated by: Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200011
- Shanghai Ninth People's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ONS group
Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
|
ONS group will receive Healing Elements ONS everyday during CRT
|
No Intervention: control group
Individualized dietary counseling during CRT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight(kg)change during concurrent chemotherapy
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: 2 years
|
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
Time Frame: 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
|
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
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
Time Frame: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
Serum albumin(g/L) change
Time Frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
|
Serum prealbumin(mg/dL) change
Time Frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
|
Serum transferrins(mg/dL)change
Time Frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
May 15, 2016
First Posted (Estimate)
May 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 19, 2018
Last Update Submitted That Met QC Criteria
March 16, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- 1405135-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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