Table 2.

Studies of Oral Cryotherapy in Hematological Malignancies

Reference	Year	Randomized	No. in Intervention/Control Group	Type of Cryotherapy	Duration of Cryotherapy	Chemo Regimen	Mucositis Staging	Intervention Group	Control Group
Dumontet15	1994	No	22/−	Ice chips + cold water	5 min pre melphalan and continued for 30 min	Mel or BEAM ±TBI	WHO, Grade 3-4	TBI: 86% No TBI: 33%
Meloni16	1996	No	18/−	Ice popsicles	5 min pre, during, and 5 after melphalan infusion	Mel or BEAM	WHO, Grade 4	6%
Aisa33	2005	No	18/7 (historical control)	Ice chips + cold water	15 min pre and during, until 90 min after melphalan infusion	Mel + Flu ± Other1	CTC, Grade 2-3	11%	86%
Mori36	2006	No	17/18b	Ice chips + cold water	15 min pre and during, until 60 or 90 min after melphalan infusion	Mel + Flu ± Othera	CTC, Grade 2-3	60 min: 11.8% 120 min: 11.1%	-
Lilleby35	2006	Yes	21/20	Ice chips	30 min pre and during, until 6 hours after infusion	Mel	CTC, Grade 3-4	14%	74%
Svanberg37	2007	Yes	39/39	Ice chips or ice water	During infusion of chemotherapy	Variable	Modified Oral Mucositis Assessment scorec	Autologous=1.6 Allogeneic=3.7	4.3 11.6
Gori39	2007	Yes	62/60	Ice chips	At least 60 min once methotrexate infusion started	Methotrexate	CTC, Grade 3-4	47%	53%
Bhatt34	2010	No	12/13 (historical cohort)	Ice chips	30 min prior to until infusion complete	Mel	CTC, Grade 3	17%	38%
Svanberg38	2010	Yes	39/39	Ice chips or cold water	During infusion of chemotherapy	Variable	WHO, Grade 3-4	36%	62%

Mel = melphalan; BEAM = carmustine, etoposide, cytarabine, and melphalan; TBI = total body irradiation; Flu = fludarabine; WHO = World Health Organization; CTC = Common Toxicity Criteria.

^aOther - included total body irradiation vs. craniospinal irradiation vs. high-dose cytarabine.

^bStudy compared two different total durations of oral cryotherapy, 60 min (n=17) and 120 min (n=18).

^cBased on modified Oral Mucositis Assessment Score; Autologous group (n=62) index ranged 0-5; Allogeneic group (n=16) index ranged 0-16.