Introduction
Materials and Methods
Study design, setting, and participants
Transplant procedures
Evaluation of OM and intervention
Oral mucositis (clinical exam) | |
---|---|
Grade 1 | Erythema of the mucosa |
Grade 2 | Patchy ulcerations or pseudomembranes |
Grade 3 | Confluent ulcerations or pseudomembranes; bleeding with trauma |
Grade 4 | Tissue necrosis; significant spontaneous bleeding; life-threatening consequences |
Cryotherapy
Statistical analysis
Results
Characteristics of participants
Variable | Cryotherapy (n = 42) | Control (n = 36) | P value | |
---|---|---|---|---|
Age | 54.8 ± 11.2 a | 53.2 ± 12.1 | 0.549 c | |
Sex | Male | 19 (45) b | 21 (58) | 0.177d |
Underlying disease | Acute myelogenous leukemia | 15 (36) | 11 (31) | 0.381e |
Malignant lymphoma | 11 (26) | 11 (31) | ||
Acute lymphoblastic leukemia | 7 (17) | 8 (22) | ||
Myelodysplastic syndrome | 4 (10) | 1 (3) | ||
Others | 5 (12) | 5 (14) | ||
Total body irradiation | No | 6 (14) | 15 (42) | 0.007d |
Yes | 36 (86) | 21 (58) | ||
Graft source | Bone marrow | 23 (55) | 14 (39) | 0.373e |
Peripheral blood | 10 (24) | 12 (33) | ||
Cord blood | 9 (21) | 10 (28) | ||
Dose of melphalan | 80 mg/m2 | 15 (36) | 9 (25) | 0.219 d |
140 mg/m2 | 27 (64) | 27 (75) | ||
Methotrexate | Yes | 28 (67) | 19 (53) | 0.154d |
No | 14 (33) | 17 (47) | ||
Leucovorin rescue | Yes | 7 (17) | 3 (8) | 0.326d |
No | 35 (83) | 33 (92) | ||
Neutrophil engraftment | 18.4 ± 5.4 | 18.8 ± 5.4 | 0.756c | |
Number of teeth | 22.7 ± 6.6 | 24.3 ± 7.2 | 0.328 c | |
Usage of denture | Yes | 11 (26) | 4 (11) | 0.080 d |
Incidence of OM and its risk factors
Variables | Odds ratio | 95% Confidence interval | P-value | |
---|---|---|---|---|
Dose of Melphalan | 80 mg/m2 | 1.000 | ||
140 mg/m2 | 3.820 | 1.085–13.455 | 0.037 | |
Methotrexate | No | 1.000 | ||
Yes | 7.605 | 2.413–23.967 | < 0.001 |
Duration of OM and its risk factors
Variables | β | 95% Confidence interval | P-value |
---|---|---|---|
Methotrexate | 0.515 | 9.712–21.636 | < 0.001 |
Subgroup analysis based on the MTX use
Variable | No Methotrexate dose | Methotrexate dose | |||||
---|---|---|---|---|---|---|---|
Cryotherapy (n = 14) | Control (n = 17) | P value | Cryotherapy (n = 28) | Control (n = 19) | P value | ||
Age | 57.9 ± 11.0a | 49.3 ± 11.6a | 0.046c | 53.3 ± 11.1a | 56.7 ± 11.7a | 0.312c | |
Sex | Male | 9 (64)b | 7 (41) | 0.200e | 10 (27)b | 14 (74) | 0.011e |
Underlying disease | Acute myelogenous leukemia | 6 (43) | 7 (41) | 0.386e | 9 (32) | 4 (21) | 0.314e |
Malignant lymphoma | 5 (36) | 3 (18) | 6 (21) | 8 (42) | |||
Acute lymphoblastic leukemia | 0 (0) | 3 (18) | 7 (25) | 5 (26) | |||
Myelodysplastic syndrome | 1 (7) | 1 (6) | 3 (11) | 0 (0) | |||
Others | 2 (14) | 3 (18) | 3 (11) | 2 (11) | |||
Total body irradiation | None | 1 (7) | 9 (53) | 0.008d | 5 (18) | 6 (32) | 0.312d |
Yes | 13 (93) | 8 (47) | 23 (82) | 13 (68) | |||
Graft source | Bone marrow | 2 (14) | 1 (6) | 0.591e | 21 (75) | 13 (68) | 0.158e |
Peripheral blood | 6 (43) | 6 (35) | 4 (14) | 6 (32) | |||
Cord blood | 6 (43) | 10 (59) | 3 (11) | 0 (0) | |||
Dose of Melphalan | 80 mg/m2 | 9 (64) | 8 (47) | 0.337d | 6 (21) | 1 (5) | 0.215d |
140 mg/m2 | 5 (36) | 9 (53) | 22 (79) | 18 (95) | |||
Leucovorin rescue | Yes | - | - | 7 (25) | 3 (16) | 0.718d | |
No | - | - | 21 (75) | 16 (84) | |||
Oral mucositis | Yes | 0 (0) | 6 (35) | 0.021d | 20 (71) | 14 (74) | 0.865e |
No | 14 (100) | 11 (65) | 8 (29) | 5 (26) | |||
Days with oral mucositis (Grades 1 to 3) | - | 8.5 ± 4.4 | 22.4. ± 11.0a | 26.2 ± 18.5a | 0.451c |