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

Primary Purpose

Severe Acute Mucositis, Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral Impact
Placebo
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Acute Mucositis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut du Cancer de Montpellier - Val d'Aurelle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral immunomodulatory solution

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The rate of grade 3 and 4 acute mucosal toxicity

Secondary Outcome Measures

Tolerance
tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)
compliance to the oral immunomodulating formula
overall quality of life (EORTC QLQ-C30 Questionnaire)
progression-free survival rates
overall survival rates

Full Information

First Posted
June 22, 2010
Last Updated
August 11, 2020
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
GORTEC
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1. Study Identification

Unique Protocol Identification Number
NCT01149642
Brief Title
Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer
Acronym
IMPATOX
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
GORTEC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Mucositis, Head and Neck Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral immunomodulatory solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Impact
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Primary Outcome Measure Information:
Title
The rate of grade 3 and 4 acute mucosal toxicity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tolerance
Description
tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)
Time Frame
through study completion, an average of 3 years
Title
compliance to the oral immunomodulating formula
Time Frame
through study completion, an average of 3 years
Title
overall quality of life (EORTC QLQ-C30 Questionnaire)
Time Frame
through study completion, an average of 3 years
Title
progression-free survival rates
Time Frame
1, 2 and 3 years
Title
overall survival rates
Time Frame
1, 2 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institut du Cancer de Montpellier - Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32936874
Citation
Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.
Results Reference
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Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

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