Head and Neck Cancer
Conditions
Keywords
recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTarginine/omega-3 fatty acids/nucleotides oral supplement
DRUGcisplatin
PROCEDUREadjuvant therapy
RADIATIONradiation therapy
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Oral Impact Product
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy | 90 days after radiotherapy | Toxicities grades 3 and 4 |
Outcome results
None listed