Childhood Acute Lymphoblastic Leukemia in RemissionPhase 3NCT01305200
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
A Phase 3 study testing supersaturated calcium phosphate rinse, questionnaire administration and quality-of-life assessment in people with Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by Children's Oncology Group at 35 sites in 3 countries.
Trial summary
This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia
- What is being tested?
- supersaturated calcium phosphate rinse, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 35 sitesin 3 countries
- Study dates
- Mar 2011to 30 Jun 2015
- Phase
- Phase 3
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
- One or more of the following donor stem cell sources (autologous or allogeneic):
- Bone marrow
- Placental blood (umbilical cord blood)
- Cytokine-mobilized peripheral blood
- Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells:
Show all 14Show fewer
- Human leukocyte antigen (HLA)-matched sibling or parent
- Partially matched family donor (mismatched for a single HLA locus [Class I])
- Fully matched unrelated marrow or peripheral blood stem cell donor
- HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (Class I or II)
- Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible
- No non-myeloablative or reduced-intensity conditioning regimens
- Eligible patients must not have received palifermin within 30 days prior to enrollment
- Eligible patients must not have received prior treatment with Caphosol
Who cannot join
- Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
United States31 sites
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Oncology Group
Arcadia, California, 91006-3776
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60614
University of Chicago
Chicago, Illinois, 60637
Nationwide Children's Hospital
Columbus, Ohio, 43205
City of Hope
Duarte, California, 91010
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The Childrens Mercy Hospital
Kansas City, Missouri, 64108
Kosair Children's Hospital
Louisville, Kentucky, 40202
Miami Children's Hospital
Miami, Florida, 33155
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118
Columbia University Medical Center
New York, New York, 10032
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Mayo Clinic
Rochester, Minnesota, 55905
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Rady Children's Hospital - San Diego
San Diego, California, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143
All Children's Hospital
St. Petersburg, Florida, 33701
Montefiore Medical Center
The Bronx, New York, 10467-2490
Ny Cancer%
Valhalla, New York, 10595
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Australia2 sites
Royal Childrens Hospital
Herston, Queensland, 4029
Princess Margaret Hospital for Children
Perth, Western Australia, 6008
Canada2 sites
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if topically administered supersaturated calcium phosphate (Caphosol), rinsed orally four times daily at the initiation of conditioning for hematopoietic stem cell transplantation (HSCT), reduces oral mucositis as demonstrated by a decrease in duration of severe oral mucositis (World Health Organization [WHO] grade 3 or 4), compared to placebo.
SECONDARY OBJECTIVES:
- To determine whether Caphosol administration, when compared to placebo, reduces oral mucositis as demonstrated by a decrease in incidence of severe oral mucositis (WHO grade 3 or 4); severity of mucositis according to mouth pain categorical rating scale and Oral Mucositis Daily Questionnaire (OMDQ); incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents); and incidence and duration of total parenteral nutrition (TPN) administration.
II. To determine whether Caphosol administration, when compared to placebo, reduces the incidence of febrile neutropenia and invasive bacterial infections.
III. To validate a new pediatric measure of oral mucositis termed the Children's International Mucositis Evaluation Scale (ChIMES).
OUTLINE: This is a multicenter study. Patients are stratified according to conditioning regimen (total-body irradiation (TBI) or melphalan vs neither TBI nor melphalan) and hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute four* times daily (QID) beginning on the first day (about day -7) of the conditioning regimen.
ARM II: Patients rinse and gargle with placebo over 1 minute QID* beginning the first day (about day -7) of the conditioning regimen.
NOTE: * Patients who reach WHO grade 3 or 4 mucositis have the option to request a total of 6 rinses daily.
In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to WHO grade =< 2 for two consecutive days OR on day 12 in patients who do not experience oral mucositis of at least WHO grade >= 1. Patients are assessed daily by trained healthcare professionals using the Oral Mucositis Daily Questionnaire (OMDQ), the Pain Rating Scale, the WHO Mucositis Scale, and the Children's International Mucositis Evaluation Scale (ChIMES) from day -1 and continuing until day 20. Patients are also observed for the incidence of total dose and duration of parenteral opioid analgesic use, duration of total parenteral nutrition (TPN) administration, febrile neutropenia, and invasive bacterial infections.
After completion of study therapy, patients are followed up for 30 days.
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia
- Being tested
- supersaturated calcium phosphate rinse, placebo, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelomonocytic, Chronic, Leukemia, Neutrophilic, Chronic, Leukemia, Myelomonocytic, Juvenile, Mucositis, Myeloproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supersaturated calcium phosphate rinseDrug
Also called Caphosol
Mouth rinse
placeboOther
Also called PLCB
Mouth rinse
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. Receives: Other: placebo; Other: questionnaire administration; Procedure: quality-of-life assessment |
| Arm II (supersaturated calcium phosphate rinse) | Experimental | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. Receives: Drug: supersaturated calcium phosphate rinse; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Secondary outcomes (10)
Incidence of Severe Oral Mucositis
Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Oral Mucositis Daily Questionnaire (OMDQ)
Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Opioid Administration = yes
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Mean days of parenteral opioid analgesic use.
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
Morphine equivalent dose in mg/kg/day
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Total Parenteral Nutrition (TPN) Administration.
Total Parenteral Nutrition = yes
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Duration of Total Parenteral Nutrition (TPN) Administration.
Mean days of total parenteral nutrition (TPN) administration.
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Febrile Neutropenia
Fever and Neutropenia = yes
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Invasive Bacterial Infections
Invasive Bacterial Infection = yes
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Severity of Mucositis
Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.
Measured: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2015
- Study completion30 Jun 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Acute Lymphoblastic Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nathaniel Treister, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305200
- Sponsor's protocol ID
- ACCL1031
- Other IDs
- NCI-2011-02635, CDR0000695718, ACCL1031, COG-ACCL1031, ACCL1031, U10CA095861
- Status last verified
- Nov 2016
- First submitted
- 25 Feb 2011
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Treister N, Nieder M, Baggott C, Olson E, Chen L, Dang H, Krailo M, August A, Sung L. Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation. Br J Cancer. 2017 Jan 3;116(1):21-27. doi: 10.1038/bjc.2016.380. Epub 2016 Nov 22.
PubMed 27875526
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01305200
- Acronym / sponsor ID
- ACCL1031
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.
Detailed description
PRIMARY OBJECTIVES:
- To determine if topically administered supersaturated calcium phosphate (Caphosol), rinsed orally four times daily at the initiation of conditioning for hematopoietic stem cell transplantation (HSCT), reduces oral mucositis as demonstrated by a decrease in duration of severe oral mucositis (World Health Organization [WHO] grade 3 or 4), compared to placebo.
SECONDARY OBJECTIVES:
- To determine whether Caphosol administration, when compared to placebo, reduces oral mucositis as demonstrated by a decrease in incidence of severe oral mucositis (WHO grade 3 or 4); severity of mucositis according to mouth pain categorical rating scale and Oral Mucositis Daily Questionnaire (OMDQ); incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents); and incidence and duration of total parenteral nutrition (TPN) administration.
II. To determine whether Caphosol administration, when compared to placebo, reduces the incidence of febrile neutropenia and invasive bacterial infections.
III. To validate a new pediatric measure of oral mucositis termed the Children's International Mucositis Evaluation Scale (ChIMES).
OUTLINE: This is a multicenter study. Patients are stratified according to conditioning regimen (total-body irradiation (TBI) or melphalan vs neither TBI nor melphalan) and hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute four* times daily (QID) beginning on the first day (about day -7) of the conditioning regimen.
ARM II: Patients rinse and gargle with placebo over 1 minute QID* beginning the first day (about day -7) of the conditioning regimen.
NOTE: * Patients who reach WHO grade 3 or 4 mucositis have the option to request a total of 6 rinses daily.
In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to WHO grade =< 2 for two consecutive days OR on day 12 in patients who do not experience oral mucositis of at least WHO grade >= 1. Patients are assessed daily by trained healthcare professionals using the Oral Mucositis Daily Questionnaire (OMDQ), the Pain Rating Scale, the WHO Mucositis Scale, and the Children's International Mucositis Evaluation Scale (ChIMES) from day -1 and continuing until day 20. Patients are also observed for the incidence of total dose and duration of parenteral opioid analgesic use, duration of total parenteral nutrition (TPN) administration, febrile neutropenia, and invasive bacterial infections.
After completion of study therapy, patients are followed up for 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Other: placebo, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. |
| Arm II (supersaturated calcium phosphate rinse) | Experimental | Drug: supersaturated calcium phosphate rinse, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
- One or more of the following donor stem cell sources (autologous or allogeneic):
- Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells:
- Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible
- Eligible patients must not have received palifermin within 30 days prior to enrollment
Key exclusion criteria (1 listed)
- Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial
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 |
|---|---|---|
| supersaturated calcium phosphate rinseAlso: CaphosolMouth rinse | Drug | Arm II (supersaturated calcium phosphate rinse) |
| placeboAlso: PLCBMouth rinse | Other | Arm I (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (placebo), Arm II (supersaturated calcium phosphate rinse) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (placebo), Arm II (supersaturated calcium phosphate rinse) |
Primary outcome
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Mean days of severe (WHO Grade 3 or 4) Mucositis.
10 secondary outcomes
Incidence of Severe Oral Mucositis
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Oral Mucositis Daily Questionnaire (OMDQ)
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Total Parenteral Nutrition (TPN) Administration.
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Duration of Total Parenteral Nutrition (TPN) Administration.
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Febrile Neutropenia
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Incidence of Invasive Bacterial Infections
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Severity of Mucositis
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27875526Treister N, Nieder M, Baggott C, Olson E, Chen L, Dang H, Krailo M, August A, Sung L. Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation. Br J Cancer. 2017 Jan 3;116(1):21-27. doi: 10.1038/bjc.2016.380. Epub 2016 Nov 22.
- Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.Link provided by the sponsor.
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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.
Nathaniel Treister, MD principal investigator
Children's Oncology Group
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing supersaturated calcium phosphate rinse, questionnaire administration and quality-of-life assessment in people with Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by Children's Oncology Group at 35 sites in 3 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 14 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 May 2017). 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?
Duration of Severe Oral Mucositis (WHO Grade 3 or 4) (time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.). 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 NCT01305200, which also lists 1 linked publication.
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 Sep 2019.