Oral MucositisPhase 2NCT00289003
The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
A Phase 2 study testing Soluble beta-1,3/1,6-glucan in people with Oral Mucositis, run by Biotec Pharmacon ASA at 3 sites in 2 countries.
Trial summary
The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy. Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Soluble beta-1,3/1,6-glucan
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2003to Jul 2006
- Phase
- Phase 2
- 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
- Patients undergoing radiotherapy or chemoradiotherapy for histologically confirmed squamous cell carcinoma of oral cavity or oropharynx (1.8-2.0 Gy/day; 5 days per week, totally 59.4-70 Gy).
- Normal mucosa at baseline (i.e. Common Toxicity Criteria (CTC) grade 0)
- >= 18 years of age
- Women of childbearing potential must use an adequate contraceptive method and have a negative pregnancy test
- Written informed consent
Who cannot join
- Patients who will receive hyperfractionated or accelerated radiotherapy
- History of malignancies within the past five years other than non-melanomatous skin cancers (with the exception of squamous cell carcinoma of the skin) or carcinoma in situ of the cervix
- Previous neoplasm in the head and neck area, whether malignant or not
- Previous radiation therapy for head and neck cancer
- If wound from curative surgery have not healed
- Patients expected to receive agents that would interfere with the investigator's ability to assess changes in the appearance of the mucositis during the study
Show all 16Show fewer
- Use of radiosensitizers
- History or clinical evidence of active significant acute or chronic diseases that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis
- Evidence of distant metastatic disease
- Expected survival of less than 12 months
- > grade 3 performance status (WHO grading)
- Granulocyte count < 2.000/mm3 and platelet count < 100,000/mm3
- Serum creatinine >= 150 micromol/L
- Total bilirubin >= 36 micromol/L, AST > 3 times the upper normal limit
- Any subject who, in the opinion of the investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons like e.g. language barriers or mental incapacity
- Participation in a clinical trial in the last 30 days Receipt of any investigational product within 30 days prior to this trial
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology
Bonn, 53119
Evangelisches Krankenhaus
Düsseldorf, 40217
United Kingdom1 site
Royal Marsden Hospital, Head and Neck Unit
London, SW3 6JJ
About this study
Official title: An Exploratory, Randomised, Parallel Group Study, Comparing the Protective Effect of Soluble Beta-1,3/1,6-Glucan or Placebo in Oral Mucositis in Head and Neck Cancer Patients Receiving Radiation Therapy or Chemoradiotherapy
The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy.
Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis
Read the detailed description
Oral mucositis is defined as inflammation and ulceration of the mucous membranes of the mouth. The condition is very painful and might put the patient at risk of serious systemic infections and is a common dose-limiting toxicity of chemotherapy and radiotherapy. The present treatment of mucositis is primarily supportive; strong analgesics in addition to oral hygiene. Prophylactic antibiotics have been used and many topical agents are available to palliate mucositis, but no standard therapy has been accepted.
Comparison: Methyl cellulose has been chosen as placebo due to its close resemblance to soluble beta-1,3/1,6-glucan in terms of general appearance and viscosity. Methyl cellulose is a viscous solution which might form a mucosal barrier. Physical barriers are considered having a protective function in oral mucositis, and methyl cellulose might be considered as an active control.
- Conditions
- Oral Mucositis
- Being tested
- Soluble beta-1,3/1,6-glucan
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble beta-1,3/1,6-glucanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.
Secondary outcomes (4)
To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
To assess time before first sign of oral mucositis
To evaluate impact of toxicities like patients' pain and swallowing difficulty
To assess the safety of the investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startOct 2003
- Study completionJul 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher M Nutting, Dr.med., Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289003
- Sponsor's protocol ID
- SMR-907-SBG-1-02-HN
- Status last verified
- May 2006
- First submitted
- 8 Feb 2006
- Last updated
- 17 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomised, Parallel Group Study, Comparing the Protective Effect of Soluble Beta-1,3/1,6-Glucan or Placebo in Oral Mucositis in Head and Neck Cancer Patients Receiving Radiation Therapy or Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT00289003
- Acronym / sponsor ID
- SMR-907-SBG-1-02-HN
- Conditions
- Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Jul 2006
- First posted
- 9 Feb 2006 (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.
The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy.
Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis
Detailed description
Oral mucositis is defined as inflammation and ulceration of the mucous membranes of the mouth. The condition is very painful and might put the patient at risk of serious systemic infections and is a common dose-limiting toxicity of chemotherapy and radiotherapy. The present treatment of mucositis is primarily supportive; strong analgesics in addition to oral hygiene. Prophylactic antibiotics have been used and many topical agents are available to palliate mucositis, but no standard therapy has been accepted.
Comparison: Methyl cellulose has been chosen as placebo due to its close resemblance to soluble beta-1,3/1,6-glucan in terms of general appearance and viscosity. Methyl cellulose is a viscous solution which might form a mucosal barrier. Physical barriers are considered having a protective function in oral mucositis, and methyl cellulose might be considered as an active control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing radiotherapy or chemoradiotherapy for histologically confirmed squamous cell carcinoma of oral cavity or oropharynx (1.8-2.0 Gy/day; 5 days per week, totally 59.4-70 Gy).
- Normal mucosa at baseline (i.e. Common Toxicity Criteria (CTC) grade 0)
- >= 18 years of age
- Women of childbearing potential must use an adequate contraceptive method and have a negative pregnancy test
- Written informed consent
Key exclusion criteria (16 listed)
- Patients who will receive hyperfractionated or accelerated radiotherapy
- History of malignancies within the past five years other than non-melanomatous skin cancers (with the exception of squamous cell carcinoma of the skin) or carcinoma in situ of the cervix
- Previous neoplasm in the head and neck area, whether malignant or not
- Previous radiation therapy for head and neck cancer
- If wound from curative surgery have not healed
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 |
|---|---|---|
| Soluble beta-1,3/1,6-glucan | Drug | – |
Primary outcome
To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.
4 secondary outcomes
To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
To assess time before first sign of oral mucositis
To evaluate impact of toxicities like patients' pain and swallowing difficulty
To assess the safety of the investigational product
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 17 Jan 2007.
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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.
Christopher M Nutting, Dr.med. principal investigator
Royal Marsden NHS Foundation Trust
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soluble beta-1,3/1,6-glucan in people with Oral Mucositis, run by Biotec Pharmacon ASA at 3 sites in 2 countries.
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 16 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 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.. 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 17 Jan 2007.