Griffiths, C., Kwon, N., Beaumont, J.L., & Paice, J.A. (2018). Cold therapy to prevent paclitaxel-induced peripheral neuropathy. Supportive Care in Cancer, 26, 3461–3469.

Evaluate the effectiveness of cold therapy on prevention of CIPN in those receiving paclitaxel-based therapy for breast cancer.

Patients wore glycerine-containing Elasto-Gel glove and sock on one extremity and nothing on the other extremity. Elasto-Gel glove/sock were cooled to -25 to -30 C in a freezer for at least three hours prior to administration; was worn for a total of 210 minutes, and changed every 45-50 minutes during infusion. A total of nine data points were collected.

• N = 33 enrolled; 29 evaluable at time point 1; 7 evaluable at time point 6; study terminated after time point 6.  
• AGE: 47.3 years (range = 35-68)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer; adjuvant therapy in 62%; neoadjuvant therapy in 38%.
• OTHER KEY SAMPLE CHARACTERISTICS: 55% married; 31% single; 14% divorced; 88% nonsmoker; 8% current active smoker; 4% quit smoking. BMI average 28.5 (17.5 to 44.4).

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Robert H. Lurie Comprehensive Cancer Center

PHASE OF CARE: Active anti-tumor treatment

Randomized controlled study of taxane-naïve patients receiving dose dense anthracycline plus paclitaxel therapy. Patients were own paired control.

Symptoms of neuropathic pain, including pain severity and sensory severity. Measured with NPSI, BPI, and QST for measurement of pain, pain severity, and sensory severity, respectively).

No significant difference in pain as measured by NPSI; all measurements of pain severity were increased with the BPI, including interference with daily activity, worst pain in the last 24 hours, average pain in 24 hours, and pain currently experienced. No significant difference in any of the five QSTs used for sensory severity, including sensitivity to innocuous touch, sensitivity to noxious stimuli, sensitivity to vibration, manual dexterity, and fine motor dexterity.

Study was stopped early at time point 6 due to high dropout rate from discomfort related to intervention; when stopped, no evidence of decreased CIPN was seen.

• Small sample (< 30)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Sample characteristics include patients with only one disease and one type of therapy. Intervention would require significant buy-in from institution as it would require freezers in location of therapy and would require nursing or other staff to change glove/sock every 45-50 minutes.

Education about current therapies. Further research needed on cryotherapy for prevention of CIPN.