Back to resultsGelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
Primary Purpose
Oral Mucositis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gelclair
First® Mouthwash BLM
Sponsored by
About this trial
This is an interventional other trial for Oral Mucositis focused on measuring Oral Mucositis, Stomatitis, Myeloablative
Eligibility Criteria
Inclusion Criteria:
- Be age ≥ 18 years old.
- Have Karnofsky performance status score ≥ 70.
- Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.
- Have anticipated in-patient status for 14 to 20 days from the time of transplant.
- Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
- Be willing and capable of completing the assessments and adhering to protocol requirements.
- Be willing and able to provide written informed consent.
To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the following criterion:
-Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning to Day +14.
Exclusion Criteria:
- Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.
- Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
- Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.
- Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
- Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
For subjects randomized to Treatment Arms 2 or 3 during observation period:
-OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period (conditioning through Day +14; i.e., missed treatment window).
Sites / Locations
- Massachusetts General Hospital
- Brigham & Women's Hospital/Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Arm 1 (Gelclair at time of conditioning)
Arm 2 (Gelclair when OM diagnosed)
Arm 3 (MMW when OM diagnosed)
Arm Description
All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive GEL.
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive MMW.
Outcomes
Primary Outcome Measures
Incidence/occurrence of any grade Oral Mucositis
Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)
Area under the curve in mouth and throat soreness (MTS)
Secondary Outcome Measures
Time to onset of any grade OM
WHO Grades 1-4
Duration of any grade OM
WHO Grades 1-4
Severity of OM
WHO Grades 1-4
Incidence of severe OM
WHO Grades 3-4
Time to onset of severe OM
WHO Grades 3-4
Duration of severe OM
WHO Grades 3-4
Magnitude of OM-related pain control
Based on subject grading of mouth and throat soreness (VAS 0 (no pain) to 10 (max pain possible)) prior to each randomized/rescue OM treatment.
Duration of pain control
Based on time at a given mouth and throat soreness level and/or need for rescue treatment to control mouth and throat soreness.
Opiate and other background pain medication use
Full Information
NCT ID
NCT03490396
First Posted
March 14, 2018
Last Updated
November 20, 2019
Sponsor
Midatech Pharma US Inc.
Collaborators
PharPoint Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03490396
Brief Title
Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
Official Title
An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash ("Magic Mouthwash") for the Management of Oral Mucositis Associated With High Dose Chemotherapy and Methotrexate in Allogeneic Stem Cell Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midatech Pharma US Inc.
Collaborators
PharPoint Research, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation (SCT) are at high risk for developing painful lesions in the oral cavity, known as oral mucositis (OM).
In this high risk adult population, the study objectives are to investigate the efficacy and tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW) initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis and recommendations of the interim data review committee.
Detailed Description
Adult patients at high risk for developing OM receiving one of the following myeloablative (MA) pre-transplant conditioning regimens prior to allogeneic transplant along with methotrexate (MTX) as part of graft vs. host disease (GVHD) prophylaxis meeting all other eligibility criteria will be enrolled:
FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and busulfan: 3.2 mg/kg both given daily on days -6 through -3.
Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg IV once on days -3 and -2
Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
• Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and 11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is acceptable.
Duration of treatment:
Arm 1: GEL treatment a minimum of 4x/day initiated from 1st day of conditioning through OM resolution (G0), up to a maximum of 20d.
Arms 2 (GEL) and 3 (MMW): Treatment a minimum of 4x/day initiated when G1 or G2 OM diagnosed during observation period (through Day +14 relative to stem cell infusion) through OM resolution (G0), up to a maximum of 20d.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral Mucositis, Stomatitis, Myeloablative
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The initial design is a prospective, randomized, single-blind (evaluator), parallel, three arm, controlled clinical study.
Masking
Outcomes Assessor
Masking Description
OM grading via the WHO oral toxicity grading scale will be performed by the trained blinded evaluator at least 3X/week (e.g., M, W and F), with ≤ 48h (±24h) in between each assessment.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 (Gelclair at time of conditioning)
Arm Type
Experimental
Arm Description
All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.
Arm Title
Arm 2 (Gelclair when OM diagnosed)
Arm Type
Active Comparator
Arm Description
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive GEL.
Arm Title
Arm 3 (MMW when OM diagnosed)
Arm Type
Active Comparator
Arm Description
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive MMW.
Intervention Type
Device
Intervention Name(s)
Gelclair
Other Intervention Name(s)
Gelclair Bioadherent Oral Gel
Intervention Description
Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
Intervention Type
Combination Product
Intervention Name(s)
First® Mouthwash BLM
Other Intervention Name(s)
Magic Mouth Wash
Intervention Description
Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash
Primary Outcome Measure Information:
Title
Incidence/occurrence of any grade Oral Mucositis
Description
Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)
Time Frame
Initial study period (initiation of conditioning through day +14 post-transplant)
Title
Area under the curve in mouth and throat soreness (MTS)
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Secondary Outcome Measure Information:
Title
Time to onset of any grade OM
Description
WHO Grades 1-4
Time Frame
Initial study period (initiation of conditioning through day +14 post-transplant)
Title
Duration of any grade OM
Description
WHO Grades 1-4
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Severity of OM
Description
WHO Grades 1-4
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Incidence of severe OM
Description
WHO Grades 3-4
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Time to onset of severe OM
Description
WHO Grades 3-4
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of severe OM
Description
WHO Grades 3-4
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Magnitude of OM-related pain control
Description
Based on subject grading of mouth and throat soreness (VAS 0 (no pain) to 10 (max pain possible)) prior to each randomized/rescue OM treatment.
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of pain control
Description
Based on time at a given mouth and throat soreness level and/or need for rescue treatment to control mouth and throat soreness.
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Opiate and other background pain medication use
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Other Pre-specified Outcome Measures:
Title
Weight change over study treatment period
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Incidence of treatment-emergent infection
Description
e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of treatment-emergent infections
Description
e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Use of anti-infectives for treatment-emergent infections
Description
Exploratory Endpoint
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of anti-infective use for treatment-emergent infections
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Dose level of anti-infectives for treatment-emergent infections
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Days of hospitalization post-SCT
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Incidence of need for a modified diet
Description
For example, soft, liquid, TPN
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of need for a modified diet
Description
For example, soft, liquid, TPN
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Treatment Compliance with randomized OM treatment
Description
Assessed by determining the number of randomized treatments actually taken relative to the number of treatments required (i.e., treatment compliance)
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Use of rescue treatments other than randomized agent for managing OM
Time Frame
While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Title
Incidence of treatment-emergent xerostomia ≥ G2
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of treatment-emergent xerostomia ≥ G2
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Use of treatments/medications to manage xerostomia
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Duration of use for treatments/medications to manage xerostomia
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Impact of OM on activities of daily living
Description
Via validated oral mucositis daily questionnaire (OMDQ)
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Diarrhea associated with OM
Description
Via validated oral mucositis daily questionnaire (OMDQ)
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
Title
Exploratory Safety/Tolerability of GEL and MMW
Description
Assessed by treatment-emergent and related adverse events/serious adverse events/unanticipated adverse device effects and subject reported tolerability.
Time Frame
Study period (initiation of conditioning through day +28 post-transplant)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be age ≥ 18 years old.
Have Karnofsky performance status score ≥ 70.
Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.
Have anticipated in-patient status for 14 to 20 days from the time of transplant.
Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
Be willing and capable of completing the assessments and adhering to protocol requirements.
Be willing and able to provide written informed consent.
To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the following criterion:
-Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning to Day +14.
Exclusion Criteria:
Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.
Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.
Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
For subjects randomized to Treatment Arms 2 or 3 during observation period:
-OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period (conditioning through Day +14; i.e., missed treatment window).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Kay Delmedico, PhD
Organizational Affiliation
Midatech Pharma US Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital/Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.gelclair.com/
Description
Gelclair Website (Study Agent)
URL
http://www.midatechpharmaus.com/
Description
Midatech Pharma US (Study Sponsor) Website
Learn more about this trial
Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
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