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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559156
First received: November 15, 2007
Last updated: May 13, 2011
Last verified: May 2011

November 15, 2007
May 13, 2011
June 2005
May 2011   (final data collection date for primary outcome measure)
Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy [ Designated as safety issue: No ]
Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
Complete list of historical versions of study NCT00559156 on ClinicalTrials.gov Archive Site
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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 Study Assessing the Impact of Parenteral Administration of the Immunomodulater Oral IMPACT® for Postoperative Radiochemotherapy in Patients With Carcinoma of the Head and Neck

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Head and Neck Cancer
  • Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement
  • Drug: cisplatin
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
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May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00559156
CDR0000574125, CLCC-IMPACT-RT, INCA-RECF0286
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Centre Val d'Aurelle - Paul Lamarque
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Study Chair: Pierre Senesse, MD Centre Val d'Aurelle - Paul Lamarque
National Cancer Institute (NCI)
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP