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

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Impact
Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy
Radiation: radiation therapy
Procedure: adjuvant therapy
Drug: cisplatin
Dietary supplement: arginine/omega-3 fatty acids/nucleotides oral supplement
Other Names:
  • Oral Impact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
Time Frame: 90 days after radiotherapy
Toxicities grades 3 and 4
90 days after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Pierre Senesse, MD, Institut du Cancer de Montpellier - Val d'Aurelle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimated)

November 16, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574125
  • CLCC-IMPACT-RT
  • INCA-RECF0286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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