Head and Neck Cancer Clinical Trial
Official title:
Phase 2 Study Assessing the Impact of Parenteral Administration of the Immunomodulater Oral IMPACT® for Postoperative Radiochemotherapy in Patients With Carcinoma of the Head and Neck
Verified date | May 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Giving a nutritional supplement containing arginine, omega-3 fatty acids, and
nucleotides to patients undergoing chemotherapy and radiation therapy may stimulate the
immune system and help the body build a stronger immune response.
PURPOSE: This phase II trial is studying how well an arginine/omega-3 fatty
acids/nucleotides nutritional supplement works in treating patients with stage III or stage
IV head and neck cancer undergoing chemotherapy and radiation therapy.
Status | Completed |
Enrollment | 46 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of head and neck cancer meeting the following criteria: - Epidermoid carcinoma - Stage III or IV disease - Must have percutaneous gastrostomy tube in place - Must have undergone prior surgery for head and neck cancer within the past 6-8 weeks - No cerebral metastases PATIENT CHARACTERISTICS: - WHO performance status (PS) 0-2 OR Karnofsky PS 60-100% - Life expectancy > 3 months - WBC > 4,000/mm³ - ANC > 2,000/mm³ - Platelet count > 100,000/mm³ - PTT = 50% - Creatinine < 130 µmol/L - Not pregnant or nursing - Fertile patients must use effective contraception - No severe sepsis - No requirement for parenteral nutrition - No pre-existing digestive pathology that results in bowel obstruction, nausea, vomiting, and/or abdominal pain > grade 1 PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Allocation: Non-Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy | No |
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