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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2007

Last Updated Date

May 13, 2011

Start Date ^ICMJE

June 2005

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00559156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement
Drug: cisplatin
Procedure: adjuvant therapy
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00559156

Other Study ID Numbers ^ICMJE

CDR0000574125, CLCC-IMPACT-RT, INCA-RECF0286

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centre Val d'Aurelle - Paul Lamarque

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Pierre Senesse, MD

Centre Val d'Aurelle - Paul Lamarque

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2011

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

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