Severe Acute MucositisIMPATOXNCT01149642

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

A study testing Oral Impact in people with Severe Acute Mucositis and Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Severe Acute Mucositis, Head and Neck Cancer
What is being tested?: Oral Impact
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteFrance
Study dates: Nov 2009to Dec 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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.

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298

Other trials in France

About this study

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

Conditions: Severe Acute Mucositis, Head and Neck Cancer
Being tested: Oral Impact, Placebo
Medical subject headings: Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01149642
Study group	Role	What they receive
Oral immunomodulatory solution	Experimental	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. Receives: Dietary Supplement: Oral Impact
Placebo	Placebo comparator	The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The rate of grade 3 and 4 acute mucosal toxicity
Measured: 3 months

Secondary outcomes (5)

Tolerance
tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)
Measured: through study completion, an average of 3 years
compliance to the oral immunomodulating formula
Measured: through study completion, an average of 3 years
overall quality of life (EORTC QLQ-C30 Questionnaire)
Measured: through study completion, an average of 3 years
progression-free survival rates
Measured: 1, 2 and 3 years
overall survival rates
Measured: 1, 2 and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Dec 2014

First posted23 Jun 2010 (estimated)
Study startNov 2009
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe Acute MucositisStudies of the same condition, open and under way.
More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149642
Sponsor's protocol ID: IMPATOX
Other IDs: VA2009/13
Acronym: IMPATOX
Status last verified: Dec 2018
First submitted: 22 Jun 2010
Last updated: 13 Aug 2020
Results posted: No

Publications

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.
PubMed 32936874

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01149642
Acronym / sponsor ID: IMPATOX / IMPATOX
Conditions: Severe Acute Mucositis, Head and Neck Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
Collaborators: GORTEC
Study start: Nov 2009
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 23 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oral immunomodulatory solution	Experimental	Dietary Supplement: Oral ImpactThe 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.
Placebo	Placebo comparator	Dietary Supplement: PlaceboThe placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (11 listed)

Tumour of nasopharynx
Mucositis
Severe sepsis
Treatment by immunomodulators in the month preceding inclusion
ATCD allergy to the components of Oral Impact.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral ImpactThe 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.	Dietary supplement	Oral immunomodulatory solution
PlaceboThe placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.	Dietary supplement	Placebo

Primary outcome

The rate of grade 3 and 4 acute mucosal toxicity
Time frame: 3 months

5 secondary outcomes

Tolerance
Time frame: through study completion, an average of 3 years
compliance to the oral immunomodulating formula
Time frame: through study completion, an average of 3 years
overall quality of life (EORTC QLQ-C30 Questionnaire)
Time frame: through study completion, an average of 3 years
progression-free survival rates
Time frame: 1, 2 and 3 years
overall survival rates
Time frame: 1, 2 and 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Derived from this study: PubMed 32936874Boisselier 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral Impact in people with Severe Acute Mucositis and Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of grade 3 and 4 acute mucosal toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01149642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.