Svanberg, A., Birgegard, G., & Ohrn, K. (2007). Oral cryotherapy reduces mucositis and opioid use after myeloablative therapy—A randomized controlled trial. Supportive Care in Cancer, 15(10), 1155–1161.

Patients sucked on ice chips or rinsed with ice cold water during administration of chemotherapy. Treatment started in direct connection with and lasted until the end of the chemotherapy session.

Patients were randomized to oral cryotherapy or standard oral care. Stratified randomization was used with regard to type of BMT.

Eighty patients aged 18 and older scheduled for bone marrow transplantation (BMT). Two patients refused.

Two patients had testicular cancer; all others had hematologic malignancies (11 diagnoses evenly distributed).

Occurred from January 2002 to August 2004

Pain intensity was rated from 0–10.

Mucositis index scores  

Modified version of the Oral Mucositis Assessment Scale (OMAS)

Morphine equivalent of pain medication and duration of medications
 

Of the patients, 71%–100% managed to keep their oral cavity constantly cooled more than half the time, 58%–75% managed to keep their oral cavity constantly cooled all the time, and 7 (18%) found oral cryotherapy unpleasant. Among those seven, four (10%) found oral cryotherapy very unpleasant.

Calculated power analysis was based on days of opioids.

The experimental group had significantly fewer days with IV opioids (0.77 +/– 2.3) and complete treatment response (CTR) (2.44+/– 4.6) t = –2.053; df = 76, p = 0.045. No other differences in opioid use were observed.

Autologous BMT highest mucositis was days 9–11 (days start with chemotherapy)

Allogeneic and unrelated donor transplants peak was days 16–18

Autologous BMT experimental group (n = 62) had significantly lower mucositis score on day 10 (1.6 +/–1.9 versus 4.3 +/–5.7; t = 2.1; df = 45; p = 0.042). The experimental group also had significantly fewer days (0.06 +/– 0.25 versus 1.71 +/– 3.22, p = 0.008) and lower total dose IV opioids.

The allogenic and URD BMT group (n = 16) had significantly lower mucositis scores on day 16 (3.7 +/– 1.8 versus 11.6 +/– 6.8; t = 2.9; df = 11; p = 0.021) but  no different opioid use.

Compliance with regimen (dose of cryotherapy)

Unable to blind cryotherapy; no indication if mucositis assessors were blinded.