Oral MucositisMucositisNCT01036633
Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
An observational study of Oral Mucositis, run by University of Arkansas.
Trial summary
The purpose of this study was to: 1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy. 2. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Infrared Thermometer
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jul 2011
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
Who may be able to join
- Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis
Who cannot join
- Women of child bearing potential who are unable to take adequate contraceptive precautions, have + pregnancy test w/in 24 hrs prior to study, pregnant, currently breastfeeding will not be able to participate in the study
About this study
Official title: Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
The purpose of this study was to:
- To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy.
- To obtain preliminary data on the most optimal method of scoring the severity of oral mucositis by comparing the results obtained using the IR thermometer to the World Health Organization (WHO) mucositis grading system and the patient self-assessment questionnaire.
- To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.
Read the detailed description
Several grading systems for oral mucositis are available including those of the World Health Organization (WHO), Radiation Therapy Oncology Group (RTOG), Western Consortium for Cancer Nursing Research WCCNR, and the National Cancer Institute Common Toxicity Criteria (NCICTC) and others However, all of these oral mucositis grading systems rely on visual examination and are therefore subjective and operator-dependent tools and suffer from significant interpersonal variability (6). With the current improvements in medicine and technology, there is definitely a need for a more objective, easy to perform, non-invasive, affordable, quantitative and reproducible tool that is operator-independent to assess the severity of oral mucositis. The introduction of such a tool would greatly improve our ability to compare the oral mucosal toxicity of antineoplastic therapies and the efficacy of various mucoprotective therapies. Furthermore, the use of such a tool can be extended to patients undergoing radiation treatment with or without chemotherapy for various malignancies including head and neck cancers.
- Conditions
- Oral Mucositis
- Being tested
- Infrared Thermometer
- Keywords
- mucositis
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared ThermometerDevice
The infrared thermometer will be used to grade the severity of oral mucositis in patients undergoing antineoplastic chemotherapy for multiple myeloma. The photothermal camera will be used to take intraoral digital images of the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Control Group no mucositis | Control patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis Receives: Device: Infrared Thermometer | |
| Non-control Group Mucositis | Patients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis Receives: Device: Infrared Thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy
Measured: 24 months
Secondary outcomes (1)
Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
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.
- More trials run by University of ArkansasThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre Vural, MD, Principal investigator, UAMSElias Anaissie, MD, Principal investigator, UAMSGal Shafirstein, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036633
- Sponsor's protocol ID
- 110227
- Acronym
- Mucositis
- Status last verified
- Mar 2012
- First submitted
- 8 Oct 2009
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Infrared Thermometer to Grade the Severity of Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
- ClinicalTrials.gov ID
- NCT01036633
- Acronym / sponsor ID
- Mucositis / 110227
- Conditions
- Oral Mucositis
- Keywords
- mucositis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Dec 2009 (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 was to:
- To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy.
- To obtain preliminary data on the most optimal method of scoring the severity of oral mucositis by comparing the results obtained using the IR thermometer to the World Health Organization (WHO) mucositis grading system and the patient self-assessment questionnaire.
- To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.
Detailed description
Several grading systems for oral mucositis are available including those of the World Health Organization (WHO), Radiation Therapy Oncology Group (RTOG), Western Consortium for Cancer Nursing Research WCCNR, and the National Cancer Institute Common Toxicity Criteria (NCICTC) and others However, all of these oral mucositis grading systems rely on visual examination and are therefore subjective and operator-dependent tools and suffer from significant interpersonal variability (6). With the current improvements in medicine and technology, there is definitely a need for a more objective, easy to perform, non-invasive, affordable, quantitative and reproducible tool that is operator-independent to assess the severity of oral mucositis. The introduction of such a tool would greatly improve our ability to compare the oral mucosal toxicity of antineoplastic therapies and the efficacy of various mucoprotective therapies. Furthermore, the use of such a tool can be extended to patients undergoing radiation treatment with or without chemotherapy for various malignancies including head and neck cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group no mucositis | – | Device: Infrared ThermometerControl patients with multiple myeloma who are not currently receiving chemotherapy and who do not suffer from oral mucositis |
| Non-control Group Mucositis | – | Device: Infrared ThermometerPatients with multiple myeloma suffering from WHO Grade 3/4 Oral Mucositis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
Key inclusion criteria (1 listed)
- Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis
Key exclusion criteria (1 listed)
- Women of child bearing potential who are unable to take adequate contraceptive precautions, have + pregnancy test w/in 24 hrs prior to study, pregnant, currently breastfeeding will not be able to participate in the study
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 |
|---|---|---|
| Infrared ThermometerThe infrared thermometer will be used to grade the severity of oral mucositis in patients undergoing antineoplastic chemotherapy for multiple myeloma. The photothermal camera will be used to take intraoral digital images of the mouth. | Device | Control Group no mucositis, Non-control Group Mucositis |
Primary outcome
To investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy
Time frame: 24 months
1 secondary outcome
Investigating the correlation between the quantitative readings obtained from oral mucosa with an IR thermometer.
Time frame: 24 months
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 22 Mar 2012.
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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.
Emre Vural, MD principal investigator
UAMS
Elias Anaissie, MD principal investigator
UAMS
Gal Shafirstein, PhD principal investigator
UAMS
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucositis, run by University of Arkansas.
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 1 inclusion and 1 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 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 investigate the feasibility of using an infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy (time frame: 24 months). 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 22 Mar 2012.