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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Dietary Supplement: Healing Elements,Methuselah Medical Technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02776124

1405135-4

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ONS group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Healing Elements,Methuselah Medical Technology

control group

No Intervention group

Description:

Individualized dietary counseling during CRT