An interventional study of Immunomodulating oral supplementation and Sip feed control in Head and Neck Squamous Cell Carcinoma, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 27 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 138 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Immunomodulating oral supplementation
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.
Dietary Supplement: Sip feed control
Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
Disease-Free Survival (DFS)
2-years DFS rate
Time frame: From date of randomization until the date of the first documented progression (local, regional, metastatic) or date of death from any cause, whichever came first, assessed up to 2 years.
Overall Survival (OS)
OS at 1, 2 and 3 years
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years.
Rate of drug compliance
the compliance is defined as the taking of more than 75 % of study product prescription
Time frame: up to 45 days
Adverse events rate
graded based on NCI-CTCAE v4.03
Time frame: until 3 months after radiotherapy
Quality of life by using the general quality of life questionnaire about cancer (QLQ-C30).
The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Time frame: Quality of life will be assessed up to 2 years after the last day of radiotherapy.
Quality of life by using the specific quality of life questionnaire about head and neck cancer (HN35)
The EORTC HN35 uses a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
Time frame: Quality of life will be assessed up to 2 years after the last day of radiotherapy.
Cachexia
Cachexia will be evaluated with weight (in kilograms)
Time frame: Cachexia will be assessed up to 3 years after the last day of radiotherapy.
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Institut du Cancer de Montpellier - Val d'Aurelle