MucositisNCT01155609
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
A study testing quality-of-life assessment, management of therapy complications and L-lysine in people with Mucositis and Oral Complications of Chemotherapy, run by University of Washington at 1 site in United States.
Trial summary
This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis, Oral Complications of Chemotherapy, Oral Complications of Radiation Therapy
- What is being tested?
- quality-of-life assessment, management of therapy complications and L-lysine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2012
- 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
- Cytologically or pathologically proven cancer of the oropharynx, lip, oral cavity, larynx, hypopharynx, nasopharynx, and salivary glands
- Predicted life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Renal function with a calculated creatinine clearance of 55 ml/min or greater, per Cockcroft-Gault formula
- Patients undergoing radiation therapy with or without concurrent chemotherapy
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Use of illicit drugs, alcohol abuse, or tobacco abuse during treatment
- Subjects may not be receiving other investigational agents
- Inability or unwillingness to comply with radiation therapy and chemotherapy regimens
- Inability or unwillingness to take daily L-Lysine supplementation as prescribed
- Use of arginine supplementation
- History of renal failure or compromise
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.
SECONDARY OBJECTIVES:
- To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.
OUTLINE:
Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up weekly until mucositis resolves.
- Conditions
- Mucositis, Oral Complications of Chemotherapy, Oral Complications of Radiation Therapy, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Lymphoepithelioma of the Nasopharynx
- Being tested
- quality-of-life assessment, management of therapy complications, L-lysine
- Medical subject headings
- Mucositis, Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Discontinue supplement; treat symptomatically
L-lysineDietary supplement
Also called L-lysine monohydrate, lysine monohydrate
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (oral complications management) | Experimental | Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity. Receives: Procedure: quality-of-life assessment; Procedure: management of therapy complications; Dietary Supplement: L-lysine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in mucositis severity and time to complete response
Complete Response will be documented by complete resolution of oral mucositis, as defined by the Radiation Therapy Oncology Group (RTOG) grading scale. If the true percent of patients that respond is 20%, we will have a 90% chance of seeing at least 1 patient in 10 with a response. If none of the 10 patients show significant improvement in time to response, then we can be 90% confident that the true rate of significant improvement is less than 20%.
Measured: Weekly post-treatment until Grade 0 mucositis is achieved
Secondary outcomes (1)
Improvement in quality of life
Measured: Weekly post-treatment until Grade 0 mucositis is achieved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionOct 2012
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 WashingtonThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Upendra Parvathaneni, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155609
- Sponsor's protocol ID
- 7101
- Other IDs
- NCI-2010-01425
- Status last verified
- May 2013
- First submitted
- 29 Jun 2010
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
- ClinicalTrials.gov ID
- NCT01155609
- Acronym / sponsor ID
- 7101
- Conditions
- Mucositis, Oral Complications of Chemotherapy, Oral Complications of Radiation Therapy, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Lymphoepithelioma of the Nasopharynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Jul 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.
This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer
Detailed description
PRIMARY OBJECTIVES:
- To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.
SECONDARY OBJECTIVES:
- To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.
OUTLINE:
Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up weekly until mucositis resolves.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (oral complications management) | Experimental | Procedure: quality-of-life assessment, Procedure: management of therapy complications, Dietary Supplement: L-lysinePatients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cytologically or pathologically proven cancer of the oropharynx, lip, oral cavity, larynx, hypopharynx, nasopharynx, and salivary glands
- Predicted life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Renal function with a calculated creatinine clearance of 55 ml/min or greater, per Cockcroft-Gault formula
- Patients undergoing radiation therapy with or without concurrent chemotherapy
Key exclusion criteria (6 listed)
- Use of illicit drugs, alcohol abuse, or tobacco abuse during treatment
- Subjects may not be receiving other investigational agents
- Inability or unwillingness to comply with radiation therapy and chemotherapy regimens
- Inability or unwillingness to take daily L-Lysine supplementation as prescribed
- Use of arginine supplementation
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 |
|---|---|---|
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (oral complications management) |
| management of therapy complicationsAlso: complications of therapy, management ofDiscontinue supplement; treat symptomatically | Procedure or surgery | Supportive care (oral complications management) |
| L-lysineAlso: L-lysine monohydrate, lysine monohydrateGiven PO | Dietary supplement | Supportive care (oral complications management) |
Primary outcome
Decrease in mucositis severity and time to complete response
Time frame: Weekly post-treatment until Grade 0 mucositis is achieved
Complete Response will be documented by complete resolution of oral mucositis, as defined by the Radiation Therapy Oncology Group (RTOG) grading scale. If the true percent of patients that respond is 20%, we will have a 90% chance of seeing at least 1 patient in 10 with a response. If none of the 10 patients show significant improvement in time to response, then we can be 90% confident that the true rate of significant improvement is less than 20%.
1 secondary outcome
Improvement in quality of life
Time frame: Weekly post-treatment until Grade 0 mucositis is achieved
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 May 2013.
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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.
Upendra Parvathaneni principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality-of-life assessment, management of therapy complications and L-lysine in people with Mucositis and Oral Complications of Chemotherapy, run by University of Washington 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 6 inclusion and 6 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 May 2013. 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. 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?
Decrease in mucositis severity and time to complete response (time frame: Weekly post-treatment until Grade 0 mucositis is achieved). 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 May 2013.