Yamagata, K., Arai, C., Sasaki, H., Takeuchi, Y., Onizawa, K., Yanagawa, T., … Bukawa, H. (2012). The effect of oral management on the severity of oral mucositis during hematopoietic SCT. Bone Marrow Transplantation, 47, 725–730.

DOI Link

Study Purpose

To determine the effectiveness of an oral management program in reducing oral mucositis (OM) incidence and severity in patients undergoing stem cell transplant (SCT)

Intervention Characteristics/Basic Study Process

Patients undergoing hematopoietic SCT were retrospectively enrolled in a study to determine if the occurrence and severity of OM was significantly different between a group of patients who received appropriate oral management and those who did not. The control group underwent SCT in 2007–2008, and the oral management group in 2009. This study included an oral evaluation, from the same oral health professionals, for all 48 enrollees prior to SCT. All serious dental issues (e.g., periodontitis, tooth extraction) were treated prior to starting SCT. Patients in the oral management group received oral care instruction with the transplant team prior to SCT. They also received an additional oral exam from the dentist and hygienist as well as instructions (including tooth brushing and oral swab use), based on their OM status. Both groups were treated with the same medications, based on the same OM toxicity scale, as graded by trained SCT nurses. OM in both groups was treated with azulene sodium sulfate and 4% lidocaine rinse.

Sample Characteristics

  • The study reported on 48 patients with cancer.
  • The age range of the sample was 16–66 years.
  • The sample was 48% male and 52% female.
  • Cancer diagnoses included malignant lymphoma, acute myelogenous leukemia, acute lymphocytic leukemia, myleodysplastic syndrome, and multiple myeloma.
  • Most of the patients had received allogeneic transplant (n = 35). 
  • Significantly more patients in the OM group received allogeneic HCT.
  • Ifosfamide, carboplatin, and etoposide (ICE) and fludarabine + melphalan/total body irradiation (TBI) conditioning regimens were significantly different between the oral management and control groups.  

Setting

This was a single-site inpatient study conducted at the Tsukuba University Hospital in Tsukuba, Japan.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was an observational, two-group trial.

Measurement Instruments/Methods

OM was graded using the National Cancer Institute's (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE, version 3.0).

Results

  • The incidence of any grade OM was significantly lower in the oral management group (p < 0.05).
  • The median of the most severe OM score was 2 for the control group and 1 for the oral management group. This difference was statistically significant (p < 0.05).
  • No significant difference was found between the groups in the duration of oral pain; however, the oral management group showed a tendency toward a shorter duration of pain (p < 0.1).
  • All patients with sepsis, in both groups, recovered with antibiotics. No significant difference was found in the incidence of sepsis or in the amount of pain medication required.

Conclusions

Oral management was associated with lower incidence of OM and lower average severity of mucositis in patients undergoing HCT.

Limitations

  • The sample size was small with fewer than 100 patients.
  • Important differences existed at baseline between groups, including the prevalence of allogeneic HCT. Key differences could have influenced results.
  • A risk of bias exists because of the lack of a control group, blinding, and random assigment, as well as the sample characteristics.
  • The study is further limited by the specific treatment group tested and the fact that it was a retroactive study .
  • The investigators did not describe specific ongoing oral self care and if this differed between groups. Additionally, patient adherence to daily oral care was not evaluated.

Nursing Implications

With this study’s evidence, nurses can educate patients and reinforce continued oral care at home as well as recommend dental evaluation prior to starting chemotherapy for patients with oral health issues. These measures should help to reduce oral side effects and reassure patients that they have some control over disease management.