Trials / Completed
CompletedNCT05101889
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Prince of Songkla University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Oral Impact® | 3 ready-to-drink bottles/day |
Timeline
- Start date
- 2013-01-11
- Primary completion
- 2017-01-31
- Completion
- 2017-01-31
- First posted
- 2021-11-01
- Last updated
- 2021-11-01
Source: ClinicalTrials.gov record NCT05101889. Inclusion in this directory is not an endorsement.