NCT02776124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

May 3, 2016

Last Update Submit

March 16, 2018

Conditions

Nasopharyngeal Carcinoma

Keywords

Nutritional statusnasopharyngeal carcinomaNutritional Counselingconcurrent chemoradiotherapyoral nutritional supplements

Outcome Measures

Primary Outcomes (1)

  • Body weight(kg)change during concurrent chemotherapy

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

Secondary Outcomes (11)

  • Disease-free survival

    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

    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

    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

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

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

  • +6 more secondary outcomes

Study Arms (2)

ONS group

EXPERIMENTAL

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

Dietary Supplement: Healing Elements,Methuselah Medical Technology

control group

NO INTERVENTION

Individualized dietary counseling during CRT

Interventions

Healing Elements,Methuselah Medical TechnologyDIETARY_SUPPLEMENT

ONS group will receive Healing Elements ONS everyday during CRT

ONS group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • age \<18 years
  • ongoing artificial nutrition
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 18, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

January 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

CN(1)