Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: arginine/omega-3 fatty acids/nucleotides oral supplement (Drug); cisplatin (Drug); adjuvant therapy (Procedure); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Official(s) and/or principal investigator(s):
Pierre Senesse, MD, Study Chair, Affiliation: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized
Primary outcome: Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
Detailed description:
OBJECTIVES:
- Assess the effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral
supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant
chemoradiotherapy in patients with stage III or IV epidermoid head and neck cancer.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy 5 days a week for 6½ weeks. Patients receive cisplatin IV
during weeks 1, 4, and 7 of radiotherapy. Patients also receive arginine/omega-3 fatty
acids/nucleotides oral supplement (Oral IMPACT®) via percutaneous gastrostomy tube 3 times
daily for 5 days before each chemotherapy treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2005
Last updated: May 23, 2008
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