Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| arginine/omega-3 fatty acids/nucleotides oral supplement | Dietary Supplement | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Impact
- description
- Oral Impact Supplement: 3 bags/day, 5 days before each chemotherapy
- interventionNames
- Dietary Supplement: arginine/omega-3 fatty acids/nucleotides oral supplement
- Drug: cisplatin
- Procedure: adjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
- timeFrame
- 90 days after radiotherapy
- description
- Toxicities grades 3 and 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available