Oral MucositisMUCIPLIQNCT01840436
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer
A study testing MUCIPLIQ in people with Oral Mucositis and Carcinoma in Situ of Upper Respiratory Tract, run by Organ, Tissue, Regeneration, Repair and Replacement at 5 sites in France.
Trial summary
MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Carcinoma in Situ of Upper Respiratory Tract
- What is being tested?
- MUCIPLIQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2013to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
- Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
- Patient age of 18 years old or higher ;
- Writing informed consent to participate to the trial ;
- Patient affiliated to the French social security system.
Who cannot join
- Treatment by non-standard fragmentation (concentrate irradiation)
- Carcinoma located in the hypopharynx or in the larynx ;
- Known hypersensitivity to heparinoids ;
- Patient who already benefited from a radiotherapy treatment ;
- Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
- Patient participating to another biomedical research ;
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- Pregnant woman, breastfeeding woman, parturient or likely to be ;
- Patient deprived of freedom, under supervision or guardianship ;
- Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, 94010
Centre de Cancérologie Léon Bérard
Lyon, 69373
CHRU de Besançon, Site du CH Belfort-Montbéliard
Montbéliard, 25200
APHP - Hôpital Tenon
Paris, Île-de-France Region, 75970
Institut de Cancérologie Gustave Roussy
Villejuif, Île-de-France Region, 94800
About this study
Official title: A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas
MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.
The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.
The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.
- Being tested
- MUCIPLIQ, Placebo
- Keywords
- MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUCIPLIQDevice
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
PlaceboDevice
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm receives a placebo (saline solution) mouthwash treatment twice a day. Receives: Device: Placebo |
| MUCIPLIQ 0.05 mg/mL | Experimental | This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day. Receives: Device: MUCIPLIQ |
| MUCIPLIQ 0.015 mg/mL | Experimental | This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day. Receives: Device: MUCIPLIQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2 or higher oral mucositis
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Secondary outcomes (5)
Number and Terms of grade 2 or higher oral mucositis
Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Administered-antalgics posology and nature
Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Pain experienced in time
Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Assessment of the Oral Health Impact Profile
Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Weight curve
Assessment of the weight curves for MUCIPLIQ and placebo groups
Measured: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Daly-Schveitzer, MD, PhD, Principal investigator, Institut Gustave Roussy, Villejuif, FranceYungan Tao, MD, Principal investigator, Institut Gustave Roussy, Villejuif, FranceDenis BARRITAULT, PhD, Study director, Organ, Tissue, Regeneration, Repair and Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840436
- Sponsor's protocol ID
- CT11M10MURT
- Acronym
- MUCIPLIQ
- Status last verified
- May 2016
- First submitted
- 23 Apr 2013
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas
- ClinicalTrials.gov ID
- NCT01840436
- Acronym / sponsor ID
- MUCIPLIQ / CT11M10MURT
- Keywords
- MUCIPLIQ, Matrix therapy, RGTA, Oral mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and ReplacementIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Apr 2013 (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.
MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.
The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.
The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboThis arm receives a placebo (saline solution) mouthwash treatment twice a day. |
| MUCIPLIQ 0.05 mg/mL | Experimental | Device: MUCIPLIQThis arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day. |
| MUCIPLIQ 0.015 mg/mL | Experimental | Device: MUCIPLIQThis arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
- Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
- Patient age of 18 years old or higher ;
- Writing informed consent to participate to the trial ;
- Patient affiliated to the French social security system.
Key exclusion criteria (9 listed)
- Treatment by non-standard fragmentation (concentrate irradiation)
- Carcinoma located in the hypopharynx or in the larynx ;
- Known hypersensitivity to heparinoids ;
- Patient who already benefited from a radiotherapy treatment ;
- Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
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 |
|---|---|---|
| MUCIPLIQMUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day. | Device | MUCIPLIQ 0.015 mg/mL, MUCIPLIQ 0.05 mg/mL |
| PlaceboPlacebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day. | Device | Placebo |
Primary outcome
Incidence of grade 2 or higher oral mucositis
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Differences of incidence of patients suffering of oral mucositis of grade 2 or higher
5 secondary outcomes
Number and Terms of grade 2 or higher oral mucositis
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Administered-antalgics posology and nature
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Pain experienced in time
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Assessment of the Oral Health Impact Profile
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
Weight curve
Time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks
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 5 May 2016.
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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.
Nicolas Daly-Schveitzer, MD, PhD principal investigator
Institut Gustave Roussy, Villejuif, France
Yungan Tao, MD principal investigator
Institut Gustave Roussy, Villejuif, France
Denis BARRITAULT, PhD study director
Organ, Tissue, Regeneration, Repair and Replacement
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUCIPLIQ in people with Oral Mucositis and Carcinoma in Situ of Upper Respiratory Tract, run by Organ, Tissue, Regeneration, Repair and Replacement at 5 sites 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 5 inclusion and 9 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 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Incidence of grade 2 or higher oral mucositis (time frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2016.