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
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|ClinicalTrials.gov Identifier: NCT00559156|
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement Drug: cisplatin Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|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 Start Date :||June 2005|
|Actual Primary Completion Date :||May 2011|
- Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559156
|Study Chair:||Pierre Senesse, MD||Institut du Cancer de Montpellier - Val d'Aurelle|