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 is ongoing, but not recruiting participants.

First Received: November 15, 2007 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559156

Purpose

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	Intervention	Phase
Head and Neck Cancer	Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement Drug: cisplatin Procedure: adjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Head and Neck Cancer Radiation Therapy Salivary Gland Disorders

Drug Information available for: Cisplatin Docosahexaenoic acids Eicosapentaenoic acid Arginine Arginine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	46
Study Start Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559156

Sponsors and Collaborators

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

Investigators

Study Chair:

Pierre Senesse, MD

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574125, CLCC-IMPACT-RT, INCA-RECF0286
Study First Received:	November 15, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00559156 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Nasopharyngeal Carcinoma
Arginine
Laryngeal Carcinoma
Adjuvants, Immunologic
Squamous Cell Carcinoma
Recurrence
Carcinoma
Hypopharyngeal Cancer

Metastatic Squamous Neck Cancer With Occult Primary
Cisplatin
Head and Neck Neoplasms
Omega 3 Fatty Acid
Epidermoid Carcinoma
Carcinoma, Squamous Cell
Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009