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

NCT ID: NCT00559156

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Impact

Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy

Group Type: EXPERIMENTAL

arginine/omega-3 fatty acids/nucleotides oral supplement

Intervention Type: DIETARY_SUPPLEMENT

cisplatin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Interventions

arginine/omega-3 fatty acids/nucleotides oral supplement

Intervention Type: DIETARY_SUPPLEMENT

cisplatin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Oral Impact

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Senesse, MD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Other Identifiers

CLCC-IMPACT-RT

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0286

Identifier Type: -

Identifier Source: secondary_id

CDR0000574125

Identifier Type: -

Identifier Source: org_study_id