Scotté, F., Tourani, J.M., Banu, E., Peyromaure, M., Levy, E., Marsan, S., . . . Oudard, S. (2005). Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. Journal of Clinical Oncology, 23, 4424–4429. 

DOI Link

Study Purpose

To determine if frozen glove (FG) treatment prevents docetaxel-induced onycholysis and skin toxicity

Intervention Characteristics/Basic Study Process

  • Patients received docetaxl 75mg/m2.
  • FG = ElastoGel (84400 APT Cedex, Akromed, France), a gel-filled sock that can supply heat or cold that was used to cover the hand to the wrist
  • The glove was refrigerated for at least three hours (–25 to –30 C), then placed on right hand for 90 minutes (intervention) 15 minutes before infusion, 1 hour of infusion, and 15 minutes after infusion. Two FGs were used sequentially to maintain a consistently low temperature.
  • The left hand was unprotected (control).
  • Onycholysis and skin toxicity were assessed at each cycle via National Cancer Institute's (NCI's) Common Terminology Criteria of Adverse Events (CTCAE) and were photo documented.

Sample Characteristics

  • N = 45 patients
  • MEDIAN AGE = 62 years
  • AGE RANGE = 41–80 years
  • MALES: 78%, FEMALES: 22%
  • KEY DISEASE CHARACTERISTICS: Prostate cancer (58%), non-small cell lung cancer (24%), breast cancer (11%), other cancers (6%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Docetaxel regimen (monotherapy, combination therapy in 58% of sample); 31% had prior chemotherapy.

Setting

  • SITE: Multicenter    
  • SETTING TYPE: Not stated   
  • LOCATION: Paris and Poitiers

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

  • Phase-II, multicenter, matched-case controlled trial

Measurement Instruments/Methods

  • Onycholysis/skin toxicity was assessed at each cycle by a medical investigator and repeated by another observer using NCI CTCAE, version 2. 
  • Ad-hoc rating scale: Patient global comfort assessment

Results

  • Median number of docetaxel cycles was six
  • Median cumulative docetaxel dose was 810 mg
  • Overall occurrence of nail toxicity was lower in those with the cooling glove (11% versus 51%, p = 0.0001). None of the hands with the cooling glove developed higher than grade 1 nail toxicity. Overall skin toxicity occurred in 24% of the glove-protected hands compared to 53% of the control hands (p = 0.0001).

Conclusions

The findings suggest that regional cooling may be of benefit to prevent nail toxicity associated with docetaxel treatment.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Questionable protocol fidelity

 

Nursing Implications

Regional cooling may have some benefit to reduce the incidence of nail and skin toxicities associated with chemotherapy. Nurses need to be aware of patients who have cold intolerance because of peripheral neuropathies or other reasons, but this appears to be a low-risk intervention that can be helpful.