NCT04001543

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective is to evaluate the efficacy on disease-free survival of a formula enriched with L-arginine, omega-3 fatty acids, and ribonucleic acids, taken for 5 days before each cycle of chemotherapy, in patients with high-risk locally-advanced HNSCC treated with postoperative concomitant chemoradiotherapy (CRT). This study is a national, multicentric double blinded, randomised phase III trial. A total of 306 patients (102 patients in group control vs 204 patients in group Oral Impact®) will be required including 10% of lost-to-follow-up patients. An immunomodulating oral supplementation compound (Oral Impact®) is compared to an isocaloric isonitrogenous control. The compound to be assessed contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients. Each patient has to take Oral Impact® or a sip feed control during 5 days before each cycle of chemotherapy. DFS will be measured from the time of randomization to the time of the first evidence of progression (local, regional, metastatic, or second primary) or death from any cause. Patients alive without carcinologic event were censored at last follow-up date. Patients treated with postoperative CRT are expected to have a 2-year DFS rate of 60% without specific diet (pControl). Including a ratio 1:2, an expected recruitment of 90 patients per year, the current study will require 131 events to detect an absolute improvement of 15% (HR=0.56, pExperimental=75%) with 0.90 statistical power using a two-sided test and a significance level of 0.05. A total of 306 patients (102 vs 204) will be required including 10% of lost of follow-up patients. The inclusion period would be 4 years, for an expected total duration of study about 8 years.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immunomodulating oral supplementation	Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
DIETARY_SUPPLEMENT	Sip feed control	Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.

Timeline

• Start date: 2019-03-14
• Primary completion: 2021-03-02
• Completion: 2026-05-01
• First posted: 2019-06-28
• Last updated: 2025-02-12

Locations

2 sites across 1 country: France