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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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
arginine/omega-3 fatty acids/nucleotides oral supplement
cisplatin
adjuvant therapy
radiation therapy
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2007
    Last Updated
    May 13, 2011
    Sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00559156
    Brief Title
    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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Non-Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    arginine/omega-3 fatty acids/nucleotides oral supplement
    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Procedure
    Intervention Name(s)
    adjuvant therapy
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Primary Outcome Measure Information:
    Title
    Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre Senesse, MD
    Organizational Affiliation
    Institut du Cancer de Montpellier - Val d'Aurelle
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    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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