Clinical trial NCT00559156: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
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
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Oral Impact Product
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
timeFrame: 90 days after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Pierre Senesse, MD
role: STUDY_CHAIR
References: