Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial
- Study type
- Clinical trial
- Design
- Prospective trial with within-patient control (each patient was her own control: dominant versus non-dominant side)
- Sample size
- 40 patients enrolled; 36 patients analysed
- Source
- JNCI: Journal of the National Cancer Institute · 2017
In plain words
Paclitaxel can cause numbness and tingling in the hands and feet. In this small study, patients with breast cancer wore frozen gloves and socks on only one side of the body while receiving the drug, and left the other side without cooling for comparison. Nerve symptoms (neuropathy) were much less common on the cooled side, and no patient left the study because they could not tolerate the cold. Talk to your doctor before using this method.
Key results
Treatment arms and regimens
Weekly paclitaxel 80 mg/m² over one hour; frozen glove and sock worn on the dominant side for 90 minutes, covering the whole duration of the drug infusion.
Weekly paclitaxel 80 mg/m² over one hour; no cryotherapy on the non-dominant side.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with breast cancer treated with weekly paclitaxel.
Endpoints
Primary endpoint: incidence of chemotherapy-induced peripheral neuropathy (CIPN) based on the change in tactile sensitivity from pre-treatment on the monofilament test at a cumulative dose of 960 mg/m². Other endpoints: warm sense deficits, subjective symptoms (Patient Neuropathy Questionnaire, PNQ), manual dexterity, and time to event and hazard ratio based on the PNQ.
Safety and side effects
Of the 40 patients, four did not reach the cumulative dose (because of pneumonia, severe fatigue, severe liver dysfunction and macular oedema). No patient withdrew from the study because of cold intolerance.
Clinical significance and place in guidelines
This small prospective study with within-patient control shows that cryotherapy can reduce the objective and subjective symptoms of paclitaxel-induced neuropathy. The abstract gives no information on changes to guidelines or official approvals; its place in current guidelines should be checked separately.
Limitations
The number of patients was small (36 evaluable patients). The design used within-patient control (comparison of the dominant and non-dominant sides) with no independent control group; the abstract does not mention randomisation or blinding. Some confidence intervals are very wide or infinite.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.