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| ID | Type | Description | Link |
|---|---|---|---|
| VA2009/13 | Other Identifier | CRLC Val d'Aurelle-Paul Lamarque |
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| Name | Class |
|---|---|
| GORTEC | OTHER |
This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral immunomodulatory solution | Experimental | The oral supplement is a 74g sachet containing 302 kcal and 16.7g proteins as well as immunonutrients such as L-Arginine, ARN and omega-3. |
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| Placebo | Placebo Comparator | The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Impact | Dietary Supplement | The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation. This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of grade 3 and 4 acute mucosal toxicity | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events) | through study completion, an average of 3 years |
| compliance to the oral immunomodulating formula |
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Inclusion Criteria:
NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Cancer de Montpellier - Val d'Aurelle | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32936874 | Derived | Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Placebo | Dietary Supplement | The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients. |
|
| through study completion, an average of 3 years |
| overall quality of life (EORTC QLQ-C30 Questionnaire) | through study completion, an average of 3 years |
| progression-free survival rates | 1, 2 and 3 years |
| overall survival rates | 1, 2 and 3 years |