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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776124
• Other study ID #: 1405135-4
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2016
• Last updated: March 16, 2018
• Start date: June 2014
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Dietary Supplement:
• Healing Elements,Methuselah Medical Technology
ONS group will receive Healing Elements ONS everyday during CRT

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight(kg)change during concurrent chemotherapy		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Disease-free survival	From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.	2 years
Secondary	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	every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Secondary	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
Secondary	Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis		every week during the course of radiotherapy, up to 6-7 weeks
Secondary	Serum albumin(g/L) change		every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Secondary	Serum prealbumin(mg/dL) change		every 2 weeks during the course of radiotherapy, up to 6-7 weeks
Secondary	Serum transferrins(mg/dL)change		every 2 weeks during the course of radiotherapy, up to 6-7 weeks