Clinical trial · Interventional
Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer
Double-blind Multicenter Phase III Trial Evaluating the Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT04001543CI-TRIAL-00085836SIMPA01active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.
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 Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunomodulating oral supplementation | Dietary Supplement | — | UNRESOLVED |
| Sip feed control | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunomodulating oral supplementation
- description
- The immunomodulating oral supplementation compound (Oral Impact®) contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.
- interventionNames
- Dietary Supplement: Immunomodulating oral supplementation
- type
- ACTIVE_COMPARATOR
- label
- Sip feed control
- description
- The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients: it is an isocaloric isonitrogenous control. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.
- interventionNames
- Dietary Supplement: Sip feed control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Surgically resected primary squamous cell carcinomas (HNSCC) of the hypopharynx, oropharynx, larynx and oral cavity with pathological stage pT1-2 pN+ (pathological stage 1 ou 2 with node) or pT3-4 any pN (pathological stage 3 ou 4 with or without node) (UICC 7th edition, 2010), * Postoperative concomitant CRT based on radiotherapy and on cisplatinum, 3 cycles, 100mg/m² by cycle, * Patients who undergone macroscopically complete resection, * High-risk characteristics patients with one or more following criteria: such as invasion of two or more regional lymph nodes, extracapsular extension of nodal disease or microscopically-involved mucosal margins of resection, perineural involvement, vascular tumor embolism, * WHO (World Health Organization) performance status 0, 1 or 2, * Age: 18 years old up to 75 years old including, Exclusion Criteria: * Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers * Sepsis at baseline * Distant metastasis * Other immunomodulating diets in the last month before inclusion * Parenteral nutrition at baseline * History of hypersensitivity and/or allergy to any component of Oral Impact ® * Patients with history of malignancies who are not disease-free for more than 5 years.
References
Publications (5)
- BACKGROUNDCooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646. PMID 15128893
- BACKGROUNDBernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641. PMID 15128894
- BACKGROUNDMachon C, Thezenas S, Dupuy AM, Assenat E, Michel F, Mas E, Senesse P, Cristol JP. Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients. Support Care Cancer. 2012 Dec;20(12):3129-35. doi: 10.1007/s00520-012-1444-5. Epub 2012 Mar 28. PMID 22453793
- BACKGROUNDVasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20. PMID 23849811
- BACKGROUNDDe Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available. PMID 14667488