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

NCT04001543 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Pierre SENESSE, MD · Institut du Cancer de Montpellier - Val d'Aurelle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2021-03-02
Completion
2026-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001543 on ClinicalTrials.gov