NCT00559156

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jun 2005

Typical duration for phase_2 head-and-neck-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

5.9 years

First QC Date

November 15, 2007

Last Update Submit

February 11, 2025

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent salivary gland cancersalivary gland squamous cell carcinomastage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

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

    Toxicities grades 3 and 4

    90 days after radiotherapy

Study Arms (1)

Oral Impact

EXPERIMENTAL

Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy

Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplementDrug: cisplatinProcedure: adjuvant therapyRadiation: radiation therapy

Interventions

arginine/omega-3 fatty acids/nucleotides oral supplementDIETARY_SUPPLEMENT
Also known as: Oral Impact
Oral Impact
cisplatinDRUG
Oral Impact
adjuvant therapyPROCEDURE
Oral Impact
radiation therapyRADIATION
Oral Impact

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

ArginineCisplatinChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Pierre Senesse, MD

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Oral Impact Product
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

June 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 13, 2025

Record last verified: 2025-02