Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer (SIMPA01)

September 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunomodulating oral supplementation

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
Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
Active Comparator: Sip feed control

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
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.
2-years DFS rate
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 years.
OS at 1, 2 and 3 years
From date of randomization until the date of death from any cause, assessed up to 3 years.
Rate of drug compliance
Time Frame: up to 45 days
the compliance is defined as the taking of more than 75 % of study product prescription
up to 45 days
Adverse events rate
Time Frame: until 3 months after radiotherapy
graded based on NCI-CTCAE v4.03
until 3 months after radiotherapy
Quality of life by using the general quality of life questionnaire about cancer (QLQ-C30).
Time Frame: Quality of life will be assessed up to 2 years after the last day of radiotherapy.

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.
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)
Time Frame: Quality of life will be assessed up to 2 years after the last day of radiotherapy.
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.
Quality of life will be assessed up to 2 years after the last day of radiotherapy.
Cachexia
Time Frame: Cachexia will be assessed up to 3 years after the last day of radiotherapy.
Cachexia will be evaluated with weight (in kilograms)
Cachexia will be assessed up to 3 years after the last day of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Pierre SENESSE, MD, Institut du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC 2017/21
  • GORTEC 2017-02 (Registry Identifier: GORTEC)
  • 2018-A00518-47 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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