MucositisPhase 1TRAUMEELNCT00584597
A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
A Phase 1 study testing Saline and Traumeel S in people with Mucositis and Head and Neck Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucositis, Head and Neck Cancer
- What is being tested?
- Saline and Traumeel S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2010
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
- Patients undergoing planned radiation therapy
- Age 18 to 99
- Nonsmokers
Who cannot join
- Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
- Patients receiving adjuvant chemotherapy
- Pediatric patients (age < 18)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.
Read the detailed description
Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.
- Conditions
- Mucositis, Head and Neck Cancer
- Being tested
- Saline, Traumeel S
- Keywords
- Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication
- Medical subject headings
- Mucositis, Head and Neck Neoplasms, Mouth Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Saline Control
Traumeel SDrug
Traumeel S 1 mL
Traumeel SDrug
Traumeel S 2mL
Traumeel SDrug
Traumeel S 3mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline Receives: Drug: Saline |
| 2 | Experimental | Traumeel S 1 mL Receives: Drug: Traumeel S |
| 3 | Experimental | Traumeel S 2 mL Receives: Drug: Traumeel S |
| 4 | Experimental | Traumeel S 3 mL Receives: Drug: Traumeel S |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- Greg Krempl, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584597
- Sponsor's protocol ID
- TRAUMEEL_S_Krempl
- Acronym
- TRAUMEEL
- Status last verified
- Dec 2010
- First submitted
- 20 Dec 2007
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
- ClinicalTrials.gov ID
- NCT00584597
- Acronym / sponsor ID
- TRAUMEEL / TRAUMEEL_S_Krempl
- Conditions
- Mucositis, Head and Neck Cancer
- Keywords
- Radiation-Induced Mucositis, Head and neck cancer, TRAUMEEL, Mucositis, Radiation, Oral cancer, Inflammation of the mouth, Homeopathic Medication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Jan 2008 (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 specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.
Detailed description
Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: SalineSaline |
| 2 | Experimental | Drug: Traumeel STraumeel S 1 mL |
| 3 | Experimental | Drug: Traumeel STraumeel S 2 mL |
| 4 | Experimental | Drug: Traumeel STraumeel S 3 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
- Patients undergoing planned radiation therapy
- Age 18 to 99
- Nonsmokers
Key exclusion criteria (4 listed)
- Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
- Patients receiving adjuvant chemotherapy
- Pediatric patients (age < 18)
- Pregnant women
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 |
|---|---|---|
| SalineSaline Control | Drug | 1 |
| Traumeel STraumeel S 1 mL | Drug | 2 |
| Traumeel STraumeel S 2mL | Drug | 3 |
| Traumeel STraumeel S 3mL | Drug | 4 |
Primary outcome
The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy
Time frame: 4 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 Dec 2010.
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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.
Greg Krempl, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline and Traumeel S in people with Mucositis and Head and Neck Cancer, run by University of Oklahoma at 1 site in United States.
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 4 inclusion and 4 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 Dec 2010. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy (time frame: 4 years). 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 13 Dec 2010.