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NCT Number: NCT01149642

Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.

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Key information

Conditions

Severe Acute Mucositis Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
  • Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.

NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.

  • Radio-chemotherapy to be given postoperatively.
  • Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
  • Performance status (grade OMS): 0, 1, 2
  • Nutritional Risk Index ≥ 83.5
  • No mucositis.
  • Age: 18-75 years
  • Life expectancy ≥ 3 months.
  • Informed consent obtained from the patient.
  • Affiliation with a social security system.

Exclusion criteria

  • Tumour of nasopharynx
  • Mucositis
  • Severe sepsis
  • Treatment by immunomodulators in the month preceding inclusion
  • ATCD allergy to the components of Oral Impact.
  • Parenteral nutrition at inclusion
  • Usual contraindications to concomitant radio-chemotherapy
  • Patient already included in another therapeutic trial involving an experimental molecule
  • Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
  • Persons deprived of liberty or under guardianship
  • Patients unable to commit to the trial schedule for geographical, social or psychological reasons.

Treatment and study plan

Oral IMPACT

Dietary Supplement

The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation.

This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes.

Placebo

Dietary Supplement

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Primary outcomes

  1. The rate of grade 3 and 4 acute mucosal toxicity

    Time frame: 3 months

Secondary outcomes

  1. Tolerance

    Time frame: through study completion, an average of 3 years

    tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)

  2. compliance to the oral immunomodulating formula

    Time frame: through study completion, an average of 3 years

  3. overall quality of life (EORTC QLQ-C30 Questionnaire)

    Time frame: through study completion, an average of 3 years

  4. progression-free survival rates

    Time frame: 1, 2 and 3 years

  5. overall survival rates

    Time frame: 1, 2 and 3 years

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Collaborators

  • GORTEC

Registry information

Official study title

Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy

Acronym: IMPATOX

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2010
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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