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

NCT ID: NCT02776124

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-01-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ONS group

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

Group Type: EXPERIMENTAL

Healing Elements,Methuselah Medical Technology

Intervention Type: DIETARY_SUPPLEMENT

ONS group will receive Healing Elements ONS everyday during CRT

control group

Individualized dietary counseling during CRT

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healing Elements,Methuselah Medical Technology

ONS group will receive Healing Elements ONS everyday during CRT

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Guopei Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

1405135-4

Identifier Type: -

Identifier Source: org_study_id