Batlle, M., Morgades, M., Vives, S., Ferra, C., Oriol, A., Sancho, J.M., ... Ribera, J.M. (2014). Usefulness and safety of oral cryotherapy in the prevention of oral mucositis after conditioning regimens with high dose melphalan for autologous stem cell transplantation for lymphoma and myeloma. European Journal of Haematology, 9(6), 487–491.

DOI Link

Study Purpose

To compare the effectiveness of oral cryotherapy (OC) to room temperature saline rinses in prevention of oral mucositis (OM) in patients with multiple myeloma (MM) and lymphoid neoplasias (NHL, HL) for autologous stem cell transplantation (ASCT)

Intervention Characteristics/Basic Study Process

An oral care protocol with sodium bicarbonate mouthwash from day 7 of ASCT until hospital discharge was implemented for all patients in the study. The intervention group received oral cryotherapy before infusion for 10 minutes, during infusion for 15 minutes, and after HDmel for 15 minutes. The control group received saline salt rinses at room temperature, but the schedule was not described in the study. Nurses assessed for oral mucositis on the day before ASCT and on days 3, 6, 9, and 12 after infusion. 

Sample Characteristics

  • N = 134  
  • MEDIAN AGE = 55-56 years (range = 23–70 years)
  • MALES: 64%, FEMALES: 35%
  • KEY DISEASE CHARACTERISTICS: MM = 58%, NHL = 41%
  • OTHER KEY SAMPLE CHARACTERISTICS: Conditioning regimens: MM = HD melphalan, NHL = BEAM (carmustine, etoposide, cytarabine, melphalan)

Setting

  • SITE: Single site, 0
  • SETTING TYPE: Inpatient  
  • LOCATION: Instituto Carlos III, Spain

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS:  Elder care  

Study Design

  • Retrospective

Measurement Instruments/Methods

  • Primary outcome measurement was development of OM (time to onset, severity/duration, and resolution), on the World Health Organization (WHO) mucositis grading scale.
  • OM assessed by nursing team on day 1 prior to ASCT and days 3, 6, 9 and 12 after ASCT.

Results

Oral mucositis was significantly lower in the intervention group (44%) compared to the control group (82%) (p < 0.001). Grades III and IV oral mucositis were also lower in the intervention group (15%) compared to the control group (31%) (p = 0.031). There was no difference between groups in the onset or duration of mucositis.

Conclusions

OC is more effective than oral saline rinses in the prevention of OM, including grades III-IV OM in patients receiving conditioning regimens.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results 
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Conditioning regimens were not homogeneous.

Nursing Implications

OM can interfere with nutrition and quality of life and can lead to secondary infections. Effective prophylaxis is needed to have good outcomes. Although this study had limitations, OC reduced severity of OM, is cost effective, and is well tolerated by patients. Therefore, it does offer an effective and inexpensive supportive measure.