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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Arginine/Omega-3 Fatty Acids/Nucleotides Oral Supplement (Oral IMPACT®) in Patients With Stage III or IV Epidermoid Head and Neck Cancer Undergoing Adjuvant Chemoradiotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CLCC-IMPACT-RT INCA-RECF0286, IMPACT RT, NCT00559156

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has a percutaneous gastrostomy tube in place
• No more than 8 weeks since undergoing surgery for head and neck cancer
• No brain metastases
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will undergo radiation therapy 5 days a week for 6½ weeks. They will also receive an infusion of cisplatin in weeks 1, 4, and 7. Patients will receive an arginine/omega-3 fatty acids/nucleotides nutritional supplement by a percutaneous gastrostomy tube three times a day for 5 days before each chemotherapy treatment.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Pierre Senesse, MD, Protocol chair		Ph: 33-4-6761-3100

Registry Information
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
Trial Start Date		2005-06-01
Registered in ClinicalTrials.gov		NCT00559156
Date Submitted to PDQ		2007-10-18
Information Last Verified		2007-11-14

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