Graft vs Host DiseasePhase 2NCT00391170
Dexamethasone to Prevent Oral Chronic Graft-versus-Host Disease
A Phase 2 study testing Topical Dexamethasone in people with Graft vs Host Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. Read more about this study
- Who is it for?
- Ages 12 to 110 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Topical Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2006to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of allogeneic hematopoietic stem cell transplantation within 60-90 days of enrollment.
- Age 12 or older.
- Ability to rinse and expectorate study medication rather than swallow it.
- Ability and willingness to come to Clinical Center for follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD.
Who cannot join
- Clinically significant oral chronic GVHD at the time of the screening.
- Active viral or fungal infection involving oral cavity not resolving by day 90.
- Platelet count less than 20,000/ml at the time of the screening appointment.
- Life expectancy less than 4 months at the time of enrollment.
- Documented hypersensitivity to dexamethasone.
- Pregnancy or lactation.
- Inability to understand the investigational nature of the study.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of Topical Dexamethasone 0.01% Solution for Prevention of Oral Chronic Graft Versus Host Disease
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the donor cells attacking the transplant recipient's tissues. In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores. Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only corticosteroid available that can be used as a mouth rinse.
Patients 12 years of age or older who have received a stem cell transplant may be eligible to participate if they are enrolled within 70 to 90 days of their transplant. Candidates are screened with a medical history and oral exam.
Read more
Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a solution that looks and tastes like the dexamethasone rinse but has no active medication). They undergo the following procedures:
Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution or placebo three times a day for 3 months.
Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study drug for the following procedures:
- Oral exam (before starting treatment and at each visit).
- Photographs of the mouth (before starting treatment and at 3 months).
- Biopsy from inside the cheek (before starting treatment). The inside of the cheek is numbed and a small piece of tissue is removed for examination by a pathologist.
- Saliva sample collection (before starting treatment).
- Blood draw (before starting treatment and at each visit).
- Quality-of-life questionnaires (before starting treatment and at 3 months).
- Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and at each visit).
- Review of medications (at each visit).
- ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are given an injection of a drug called "ACTH" or "cosyntropin" which is a version of a hormone normally produced by the pituitary gland. Blood samples are drawn before the injection and at 30 and 60 minutes after the injection to measure levels of the hormone cortisol.
After treatment ends, participants are contacted by telephone every month for 6 months to report any symptoms of cGVHD, and they return to the clinic at 6 months for a final evaluation.
Read the detailed description
Prevention of oral chronic graft versus host disease (GVHD) by topical agents is an attractive strategy because it would potentially avoid the adverse effects associated with systemic immunosuppression. Topically administered dexamethasone solution is a commonly used agent for the prophylaxis of oral inflammatory conditions including GVHD. However, the efficacy and systemic effects of topically administered dexamethasone solution are unknown. We therefore propose this trial designed to evaluate the efficacy and safety of topical dexamethasone solution for prevention of oral chronic GVHD in stem cell transplant recipients.
This pilot phase II study will follow a randomized, double-blind, placebo controlled, parallel group design. Consenting subjects who have undergone hematopoietic stem cell transplantation at the NIH Clinical Center and the surrounding transplant clinics will be randomized 50/50 to receive dexamethasone 0.01% solution or placebo as an oral rinse for 3 months starting 90-100 days post-transplant. Subjects will be evaluated monthly after the start of intervention. Diagnostic and research evaluations will include a complete oral examination, oral mucosal biopsy prior to the beginning of the intervention (day -7) and at the time of development of oral chronic GVHD or at the completion of intervention in the absence of clinical GVHD. We will measure serum dexamethasone levels and perform short cosyntropin (ACTH stimulation) test at the end of the 3 months of intervention or onset of clinically significant GVHD.
The primary objective of the study is to evaluate the safety and efficacy of topical dexamethasone 0.01% solution used as an oral rinse for prevention of oral chronic GVHD. Our primary endpoint will be the proportion of subjects that develop clinically significant (severity score 3 or higher) oral chronic GVHD after three months.
Secondary objectives will include the impact of oral chronic GVHD on the quality of life, characterization of the changes in tissue and salivary biomarkers associated with development of oral graft versus host disease, and measures of the effects of topical dexamethasone on hypothalamo-pituitary-adrenal axis. Secondary outcomes will include oral cavity specific quality of life as measured by Oral Health Impact Profile (OHIP)-14 questionnaire, oral discomfort levels, improvement in general quality of life scores, and severity of oral chronic GVHD as measured by the site-specific GVHD scoring system.
- Conditions
- Graft vs Host Disease
- Being tested
- Topical Dexamethasone, Placebo
- Keywords
- Oral Chronic GVHD, Topical Dexamethasone, Tissue Markers, Salivary Proteomics, Quality of Life, Oral Chronic Graft Versus Host Disease, Oral Pain, Mouth Pain
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical DexamethasoneDrug
dexamethasone 0.01%
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone oral rinse in stem cell transplant participants | Experimental | Dexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration. Receives: Drug: Topical Dexamethasone |
| Placebo oral rinse in stem cell transplant participants | Placebo comparator | Placebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants That Developed Severity Score 3 or Higher Oral Chronic Graft Versus Host Disease (GVHD).
Participants that developed clinically significant (severity score 3 or higher) oral chronic graft versus host disease (GVHD) within 90 days of initiating treatment. Oral chronic GVHD is defined by Lichen Planus (Oral GVHD) Severity Scale (Thongprasom et al., 2003).
Score 5: White striae with erosive area > 1 cm^2 Score 4: White striae with erosive area < 1 cm^2 Score 3: White striae with erythematous area > 1 cm^2 Score 2: White striae with erythematous area < 1 cm^2 Score 1: Mild white striae only Score 0: No lesions, normal mucosa
Measured: Day 90
Secondary outcomes (3)
Participants With Chronic Oral Graft Versus Host Disease (GVHD) Based on Severity Scores
Participants that developed oral chronic graft versus host disease (GVHD) within 90 days of initiating treatment. Oral chronic GVHD is defined by Lichen Planus (Oral GVHD) Severity Scale (Thongprasom et al., 2003).
Score 5: White striae with erosive area > 1 cm^2 Score 4: White striae with erosive area < 1 cm^2 Score 3: White striae with erythematous area > 1 cm^2 Score 2: White striae with erythematous area < 1 cm^2 Score 1: Mild white striae only Score 0: No lesions, normal mucosa
Measured: Day 90
Participants With Systemic Absorption of Topical Dexamethasone
Participants with systemic absorption of topical dexamethasone based on plasma dexamethasone level < 30 ng/dL.
Measured: 3 months
Participants With Suppressed Adrenal Cortical Function Due to Topical Dexamethasone
Number of participants who are not on systemic steroids with suppressed adrenal cortical function after completing study intervention phase (3 month) based on serum morning cortisol levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study start24 Nov 2006
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph A Clara, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391170
- Sponsor's protocol ID
- 070005
- Other IDs
- 07-H-0005
- Status last verified
- 24 Feb 2021
- First submitted
- 20 Oct 2006
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chakrabarti S, Childs R. Allogeneic immune replacement as cancer immunotherapy. Expert Opin Biol Ther. 2003 Oct;3(7):1051-60. doi: 10.1517/14712598.3.7.1051.
PubMed 14519070Tykodi SS, Warren EH, Thompson JA, Riddell SR, Childs RW, Otterud BE, Leppert MF, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation for metastatic renal cell carcinoma after nonmyeloablative conditioning: toxicity, clinical response, and immunological response to minor histocompatibility antigens. Clin Cancer Res. 2004 Dec 1;10(23):7799-811. doi: 10.1158/1078-0432.CCR-04-0072.
PubMed 15585611Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. doi: 10.1053/bbmt.2003.50026.
PubMed 12720215Thongprasom K, Luengvisut P, Wongwatanakij A, Boonjatturus C. Clinical evaluation in treatment of oral lichen planus with topical fluocinolone acetonide: a 2-year follow-up. J Oral Pathol Med. 2003 Jul;32(6):315-22. doi: 10.1034/j.1600-0714.2003.00130.x.
PubMed 12787037
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Topical Dexamethasone 0.01% Solution for Prevention of Oral Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT00391170
- Acronym / sponsor ID
- 070005
- Conditions
- Graft vs Host Disease
- Keywords
- Oral Chronic GVHD, Topical Dexamethasone, Tissue Markers, Salivary Proteomics, Quality of Life, Oral Chronic Graft Versus Host Disease, Oral Pain, Mouth Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 24 Nov 2006 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the donor cells attacking the transplant recipient's tissues. In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores. Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only corticosteroid available that can be used as a mouth rinse.
Patients 12 years of age or older who have received a stem cell transplant may be eligible to participate if they are enrolled within 70 to 90 days of their transplant. Candidates are screened with a medical history and oral exam.
Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a solution that looks and tastes like the dexamethasone rinse but has no active medication). They undergo the following procedures:
Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution or placebo three times a day for 3 months.
Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study drug for the following procedures:
- Oral exam (before starting treatment and at each visit).
- Photographs of the mouth (before starting treatment and at 3 months).
- Biopsy from inside the cheek (before starting treatment). The inside of the cheek is numbed and a small piece of tissue is removed for examination by a pathologist.
- Saliva sample collection (before starting treatment).
- Blood draw (before starting treatment and at each visit).
- Quality-of-life questionnaires (before starting treatment and at 3 months).
- Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and at each visit).
- Review of medications (at each visit).
- ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are given an injection of a drug called "ACTH" or "cosyntropin" which is a version of a hormone normally produced by the pituitary gland. Blood samples are drawn before the injection and at 30 and 60 minutes after the injection to measure levels of the hormone cortisol.
After treatment ends, participants are contacted by telephone every month for 6 months to report any symptoms of cGVHD, and they return to the clinic at 6 months for a final evaluation.
Detailed description
Prevention of oral chronic graft versus host disease (GVHD) by topical agents is an attractive strategy because it would potentially avoid the adverse effects associated with systemic immunosuppression. Topically administered dexamethasone solution is a commonly used agent for the prophylaxis of oral inflammatory conditions including GVHD. However, the efficacy and systemic effects of topically administered dexamethasone solution are unknown. We therefore propose this trial designed to evaluate the efficacy and safety of topical dexamethasone solution for prevention of oral chronic GVHD in stem cell transplant recipients.
This pilot phase II study will follow a randomized, double-blind, placebo controlled, parallel group design. Consenting subjects who have undergone hematopoietic stem cell transplantation at the NIH Clinical Center and the surrounding transplant clinics will be randomized 50/50 to receive dexamethasone 0.01% solution or placebo as an oral rinse for 3 months starting 90-100 days post-transplant. Subjects will be evaluated monthly after the start of intervention. Diagnostic and research evaluations will include a complete oral examination, oral mucosal biopsy prior to the beginning of the intervention (day -7) and at the time of development of oral chronic GVHD or at the completion of intervention in the absence of clinical GVHD. We will measure serum dexamethasone levels and perform short cosyntropin (ACTH stimulation) test at the end of the 3 months of intervention or onset of clinically significant GVHD.
The primary objective of the study is to evaluate the safety and efficacy of topical dexamethasone 0.01% solution used as an oral rinse for prevention of oral chronic GVHD. Our primary endpoint will be the proportion of subjects that develop clinically significant (severity score 3 or higher) oral chronic GVHD after three months.
Secondary objectives will include the impact of oral chronic GVHD on the quality of life, characterization of the changes in tissue and salivary biomarkers associated with development of oral graft versus host disease, and measures of the effects of topical dexamethasone on hypothalamo-pituitary-adrenal axis. Secondary outcomes will include oral cavity specific quality of life as measured by Oral Health Impact Profile (OHIP)-14 questionnaire, oral discomfort levels, improvement in general quality of life scores, and severity of oral chronic GVHD as measured by the site-specific GVHD scoring system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone oral rinse in stem cell transplant participants | Experimental | Drug: Topical DexamethasoneDexamethasone 0.01% (0.5mg/5 mL) oral rinse solution in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration. |
| Placebo oral rinse in stem cell transplant participants | Placebo comparator | Drug: PlaceboPlacebo oral rinse in post allogeneic hematopoietic stem cell transplant participants. Rinse oral cavity three times daily for two minutes with ten milliliters then expectorate. Complete for three months duration. |
Who may qualify
- Ages
- 12 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
- Clinically significant oral chronic GVHD at the time of the screening.
- Active viral or fungal infection involving oral cavity not resolving by day 90.
- Platelet count less than 20,000/ml at the time of the screening appointment.
- Life expectancy less than 4 months at the time of enrollment.
- Documented hypersensitivity to dexamethasone.
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 |
|---|---|---|
| Topical Dexamethasonedexamethasone 0.01% | Drug | Dexamethasone oral rinse in stem cell transplant participants |
| PlaceboPlacebo | Drug | Placebo oral rinse in stem cell transplant participants |
Primary outcome
Participants That Developed Severity Score 3 or Higher Oral Chronic Graft Versus Host Disease (GVHD).
Time frame: Day 90
Participants that developed clinically significant (severity score 3 or higher) oral chronic graft versus host disease (GVHD) within 90 days of initiating treatment. Oral chronic GVHD is defined by Lichen Planus (Oral GVHD) Severity Scale (Thongprasom et al., 2003). Score 5: White striae with erosive area > 1 cm^2 Score 4: White striae with erosive area < 1 cm^2 Score 3: White striae with erythematous area > 1 cm^2 Score 2: White striae with erythematous area < 1 cm^2 Score 1: Mild white striae only Score 0: No lesions, normal mucosa
3 secondary outcomes
Participants With Chronic Oral Graft Versus Host Disease (GVHD) Based on Severity Scores
Time frame: Day 90
Participants With Systemic Absorption of Topical Dexamethasone
Time frame: 3 months
Participants With Suppressed Adrenal Cortical Function Due to Topical Dexamethasone
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14519070Chakrabarti S, Childs R. Allogeneic immune replacement as cancer immunotherapy. Expert Opin Biol Ther. 2003 Oct;3(7):1051-60. doi: 10.1517/14712598.3.7.1051.
- Background: PubMed 15585611Tykodi SS, Warren EH, Thompson JA, Riddell SR, Childs RW, Otterud BE, Leppert MF, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation for metastatic renal cell carcinoma after nonmyeloablative conditioning: toxicity, clinical response, and immunological response to minor histocompatibility antigens. Clin Cancer Res. 2004 Dec 1;10(23):7799-811. doi: 10.1158/1078-0432.CCR-04-0072.
- Background: PubMed 12720215Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. doi: 10.1053/bbmt.2003.50026.
- Background: PubMed 12787037Thongprasom K, Luengvisut P, Wongwatanakij A, Boonjatturus C. Clinical evaluation in treatment of oral lichen planus with topical fluocinolone acetonide: a 2-year follow-up. J Oral Pathol Med. 2003 Jul;32(6):315-22. doi: 10.1034/j.1600-0714.2003.00130.x.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Graft vs Host Disease
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.
Joseph A Clara, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Dexamethasone in people with Graft vs Host Disease, run by National Heart, Lung, and Blood Institute (NHLBI) 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 8 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 10 Feb 2022. 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 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?
Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants That Developed Severity Score 3 or Higher Oral Chronic Graft Versus Host Disease (GVHD). (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391170, which also lists 4 linked publications.
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 10 Feb 2022.