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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Healing Elements,Methuselah Medical Technology

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shanghai ninth people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ONS group

control group

Arm Description

Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)

Individualized dietary counseling during CRT

Outcomes

Primary Outcome Measures

Body weight(kg)change during concurrent chemotherapy

Secondary Outcome Measures

Disease-free survival

From date of randomization until date of first documented disease progression or death from any cause, assessed up to 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

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

Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis

Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis

Serum albumin（g/L) change

Serum prealbumin（mg/dL) change

Serum transferrins（mg/dL）change

Full Information

NCT ID

NCT02776124

First Posted

May 3, 2016

Last Updated

March 16, 2018

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborators

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02776124

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborators

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nutritional status, nasopharyngeal carcinoma, Nutritional Counseling, concurrent chemoradiotherapy, oral nutritional supplements

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ONS group

Arm Type

Experimental

Arm Description

Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)

Arm Title

control group

Arm Type

No Intervention

Arm Description

Individualized dietary counseling during CRT

Intervention Type

Dietary Supplement

Intervention Name(s)

Healing Elements,Methuselah Medical Technology

Intervention Description

ONS group will receive Healing Elements ONS everyday during CRT

Primary Outcome Measure Information:

Title

Body weight(kg)change during concurrent chemotherapy

Time Frame

every week during the course of radiotherapy, up to 6-7 weeks

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.

Time Frame

2 years

Title

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

Description

participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks

Time Frame

every 2 weeks during the course of radiotherapy, up to 6-7 weeks

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis

Time Frame

every week during the course of radiotherapy, up to 6-7 weeks

Title

Serum albumin（g/L) change

Time Frame

every 2 weeks during the course of radiotherapy, up to 6-7 weeks

Title

Serum prealbumin（mg/dL) change

Time Frame

every 2 weeks during the course of radiotherapy, up to 6-7 weeks

Title

Serum transferrins（mg/dL）change

Time Frame

every 2 weeks during the course of radiotherapy, up to 6-7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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