Due to major advances in early detection and improved therapies, patients with breast cancer (BC) are living longer. Unfortunately, many BC therapies are known to carry a substantial risk of adverse long-term effects. One of the most common and debilitating adverse effects is chemotherapy-induced peripheral neuropathy (CIPN), which is associated with widely used anti-breast cancer drugs such as taxane chemotherapy. CIPN is difficult to prevent and to treat. Many pharmacologic therapies have been evaluated including antidepressants, anticonvulsants, analgesics, and supplements; unfortunately, all studies, except for a phase III evaluation of duloxetine, have demonstrated no improvement or even worsening of CIPN symptoms, and no effective prevention strategy has been identified. A few small, non-randomized studies in which patients served as their own controls, suggest a possible benefit of cryotherapy or compression therapy on prevention of CIPN symptoms. We will conduct a phase IIB randomized trial of up to 100 subjects (60-70 subjects expected under most likely scenarios) with early stage BC during treatment with taxane chemotherapy. Participants will be randomized to either cryotherapy, compression therapy, or placebo. The primary goal of this study is to select the best intervention to be carried forward to a larger phase III trial, with a high probability of a correct selection if one intervention is truly superior to the other using a pre-specified effect size.
Our aims are to (1) to identify a preferred therapy between cryotherapy delivered via frozen gloves and socks, compression therapy delivered via compression gloves and socks, or placebo (?loose? gloves and socks) at prevention of patient reported CIPN symptoms after 12 weeks of therapy. We will define success as a change in the FACT NTX questionnaire of <5 from baseline to 12-week evaluation; (2) To evaluate the effect of cryotherapy, compression therapy, and placebo on objective sensory and motor functional tests. We will compare changes from baseline to 12-weeks with the tuning fork, Neuropen, timed get up and go test, and tandem/unipedal stance test. To date, we have not been successful at treating or preventing CIPN. This study evaluates the use of promising and readily available, non-pharmacologic, and low cost interventions aimed at prevention of CIPN. If found beneficial, these treatments may bring us one step closer to improving the lives of cancer survivors.
Chemotherapy induced peripheral neuropathy can be a devastating long-term complication of early-stage breast cancer treatment affecting patients? quality of life and function long after treatment ends; and to date we have not been successful at preventing or treating CIPN. This study evaluates the use of promising and readily available, non-pharmacologic, and low cost interventions aimed at prevention of CIPN. If found beneficial, these treatments may bring us one step closer to improving the lives of cancer survivors.
