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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement; Drug: cisplatin; Procedure: adjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00559156
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Impact	arginine/omega-3 fatty acids/nucleotides oral supplement	Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy
Oral Impact	cisplatin	Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy
Oral Impact	adjuvant therapy	Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy
Oral Impact	radiation therapy	Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy

Primary Outcome Measures

Name	Time	Method
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