Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage I… (NCT00559156) | Clinical Trial Compass
CompletedPhase 2
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
46 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT00559156
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle