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Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer


Phase 3
18 Years
85 Years
Not Enrolling
Both
Oropharynx Cancer, Hypopharynx Cancer

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Trial Information

Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer


The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is
external radiotherapy. However, one of the associated toxicities is the occurrence of
mucositis which can be a limiting factor in the treatment (dose reduction or treatment
interruption can limit patient's survival), patient's quality of life decreases and severe
complications can occur. The treatment of mucositis is mainly symptomatic; a randomized
study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory
drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients
has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have
developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and
which could prevent radiation-induced mucositis. This study will evaluate the efficiency of
mouthwash with Homeodent® in a large randomized trial.


Inclusion Criteria:



- Male or female patient aged ≥ 18 years

- ECOG PS ≤ 2

- Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid
carcinoma, whatever the stage

- Patient receiving a minimum radiation dose of 60 Gy

- Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx

- Mandatory affiliation with a health insurance system

- Signed, written informed consent

Exclusion Criteria:

- Previous irradiation to the oral mucosa and/or oropharynx

- Pre-existing mucositis

- Pregnant or lactating woman (negative serum or urinary pregnancy test for women with
child-bearing potential)

- Patient included in another study including experimental radiotherapy possibly toxic
to the mucosa

- difficult follow up of the patient

- patient deprived of civil rights

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)

Outcome Time Frame:

At the end of irradiation period (6 weeks)

Safety Issue:

No

Principal Investigator

Pascal POMMIER

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, LYON

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

HOMEODENT

NCT ID:

NCT01066741

Start Date:

May 2009

Completion Date:

August 2011

Related Keywords:

  • Oropharynx Cancer
  • Hypopharynx Cancer
  • Epidermoid carcinoma
  • Hypopharynx
  • Oropharynx
  • Oral cavity
  • Oral mucosa
  • Cavum
  • Severe Oral mucositis
  • Radiotherapy
  • Phytotherapy
  • Stomatitis
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms
  • Mucositis

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