Trial Outcomes & Findings for Prevention of Oral Mucositis Using Photobiomodulation Therapy (NCT NCT04227340)
NCT ID: NCT04227340
Last Updated: 2022-10-04
Results Overview
Feasibility was assessed through the number of successful treatments (957) administered by the total number of attempted treatments (1023), providing the percentage of successful treatment administered. Daily treatment included 6 sites of PBM application, with application documented as receiving all 6 applications, in part treatment (at least one to five sites) or no treatment. A successful treatment was defined as successfully administered to 4 or more sites. Reasons for partial or no treatment was documented. Criteria for feasibility was 75%.
COMPLETED
NA
43 participants
Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)
2022-10-04
Participant Flow
43 patients were enrolled between February 2020 and May 2021 Historical Matched Controls were not enrolled on this study, therefore; they are not included in the protocol enrollment number.
Forty-three (43) participants were enrolled with 3 participants withdrawing consent prior to the start of treatment. Historical Matched Controls: Information obtained through chart reviews; matched on age, sex, primary diagnosis, and conditioning regimens; mucositis grade collected; previously treated on Bone Marrow transplant studies and non-protocol treatment plans (NPTP): 12 on NPTP; 2 on NCT01807611; 9 on NCT03849651; 17 on NCT02790515; not treated with Photobiomodulation.
Participant milestones
| Measure |
Photobiomodulation Therapy (PBM)
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Photobiomodulation Therapy (PBM)
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Prevention of Oral Mucositis Using Photobiomodulation Therapy
Baseline characteristics by cohort
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
9.9 years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
10.4 years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan/White
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Otherwise Specified
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Conditioning Regimen (choice=Chemotherapy)
Yes
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Conditioning Regimen (choice=Chemotherapy)
No
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Conditioning Regimen (choice=Radiation)
No
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Conditioning Regimen (choice=Radiation)
Yes
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Primary Disease
Acute Lymphoblastic Leukemia (ALL)
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Primary Disease
Acute Myeloid Leukemia (AML)
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Primary Disease
Chronic Myeloid Leukemia (CML)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All PrOM study patients who received allogeneic transplant. Forty participants were treated daily for a total of 1023 patient encounters, during 66 patient encounters we were unable to treat 4 or more sites
Feasibility was assessed through the number of successful treatments (957) administered by the total number of attempted treatments (1023), providing the percentage of successful treatment administered. Daily treatment included 6 sites of PBM application, with application documented as receiving all 6 applications, in part treatment (at least one to five sites) or no treatment. A successful treatment was defined as successfully administered to 4 or more sites. Reasons for partial or no treatment was documented. Criteria for feasibility was 75%.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=1023 Treatment Encounters
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Feasibility of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).
|
93 percentage of successful treatments
Interval 93.0 to 94.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients who received at least 75% of the attempted PMB(n=40).
It was estimated from a retrospective review of HCT patients that 71% of participants undergoing a HCT developed grade 3 mucositis. With an estimated clinically meaningful effect size of 20% for PBM, the estimated percentage of PBM participant to develop grade 3 mucositis was set at 51%. An interim analysis was conducted after the enrollment of 40 participants.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Efficacy of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: Within each grade of mucositis (1-3) participants and controls were ranked against each other by days of mucositis duration. Each participant and control had 3 rankings for the 3 mucositis grades. The weighted average for each participant and control was calculated. Within each group (participant vs. control) there was a ranking (1-35 with the lower score being more severe mucositis). Statistical analysis then compared the weighted average between the two groups.
Patients were ranked according to the severity of their mucositis (a weighted average of mucositis intensity (grade 1-3) by number of days duration)
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls
Grade 1
|
143 Days of mucositis within each grade
|
177 Days of mucositis within each grade
|
—
|
|
Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls
Grade 2
|
80 Days of mucositis within each grade
|
178 Days of mucositis within each grade
|
—
|
|
Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls
Grade 3
|
19 Days of mucositis within each grade
|
46 Days of mucositis within each grade
|
—
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 1 at various days, their duration of grade 1 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 1 OM were calculated between PBM treated and untreated
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.
|
3.58 Days
Standard Deviation 2.91
|
4.43 Days
Standard Deviation 3.85
|
4 Days
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 1 at various days, their duration of grade 1 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 1 OM were calculated between PBM treated and untreated.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
|
3 Days
Interval 0.0 to 10.0
|
4 Days
Interval 0.0 to 19.0
|
4 Days
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 2 at various days, their duration of grade 2 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 2 OM were calculated between PBM treated and untreated.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
|
2 Days
Standard Deviation 2.10
|
4.45 Days
Standard Deviation 4.99
|
3.23 Days
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 2 at various days, their duration of grade 2 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 2 OM were calculated between PBM treated and untreated.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
|
1.5 Days
Interval 0.0 to 6.0
|
2.5 Days
Interval 0.0 to 16.0
|
2 Days
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 3 at various days, their duration of grade 3 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 3 OM were calculated between PBM treated and untreated.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.
|
0.47 Days
Standard Deviation 1.15
|
1.15 Days
Standard Deviation 2.18
|
0.81 Days
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)Population: All patients in treatment and control group who developed grade 3 at various days, their duration of grade 3 data was used.
Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 3 OM were calculated between PBM treated and untreated.
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
n=80 Participants
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
|
0 Days
Interval 0.0 to 5.0
|
0 Days
Interval 0.0 to 8.0
|
0 Days
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: From the time of admission to dischargePopulation: All patients in treatment and control group during their hospitalization for Bone Marrow Transplant (BMT).
Total days of hospitalization between the treated and control group
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Days of Hospitalization Between Groups
|
32.4 Days of hospitalization
Standard Deviation 6.40
|
40.2 Days of hospitalization
Standard Deviation 15.7
|
—
|
SECONDARY outcome
Timeframe: From the time of admission to dischargePopulation: All patients in treatment and control group during their hospitalization for BMT.
Total days of hospitalization between the treated and control group
Outcome measures
| Measure |
Photobiomodulation Therapy (PBM)
n=40 Participants
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
|
Historical Matched Controls
n=40 Participants
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
Overall
Photobiomodulation Treated:
Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) patients undergoing Allogeneic transplant treated with Photobiomodulation
Historical control matched: Patients matched on age, sex, primary diagnosis, conditioning regimen who were previously treated on Bone Marrow transplant studies and non-protocol treatment plans. Information was obtained through chart reviews.
|
|---|---|---|---|
|
Days of Hospitalization Between Groups
|
32 Days of hospitalization
Interval 23.0 to 49.0
|
35 Days of hospitalization
Interval 23.0 to 105.0
|
—
|
Adverse Events
Photobiomodulation Therapy (PBM)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Belinda Mandrell, PhD, RN
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place