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

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ClinicalTrials.gov Identifier: NCT01149642
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : March 15, 2016
Sponsor:
Collaborator:
GORTEC
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Acute Mucositis Head and Neck Cancer Dietary Supplement: Oral Impact Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral immunomodulatory solution
The oral supplement is a 74g sachet containing 302 kcal and 16.7g proteins as well as immunonutrients such as L-Arginine, ARN and omega-3.
Dietary Supplement: Oral Impact

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 Comparator: Placebo
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Dietary Supplement: Placebo
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.




Primary Outcome Measures :
  1. The rate of grade 3 and 4 acute mucosal toxicity [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149642


Locations
France
Centre Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
GORTEC

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT01149642     History of Changes
Other Study ID Numbers: IMPATOX
VA2009/13 ( Other Identifier: CRLC Val d'Aurelle-Paul Lamarque )
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases