Short summary

Female patients treated for early breast cancer receives preventive chemotherapy to reduce the risk of recurrent cancer. Preventive chemotherapy contains Paclitaxel, a cytostatic drug with the possible side effect of sensory disturbances (neuropathy) in hands and feet. This can ultimately lead to a discontinuing of treatment, to avoid permanent neuropathy, consequently increasing the risk of recurrent breast cancer.

Rationale

Females receiving surgery of breast cancer, which have a high risk of recurrence, are offered preventive chemotherapy with Paclitaxel. Paclitaxel are causing chemotherapy-induced neuropathy (CIPN) at about 30% of the treated females, which often occur at the end of treatment therapy, resulting in reduction or termination of further treatment. CIPN inflicts major pain and suffering among the patients, in the form of alternated sensation, stinging pain and numbness possibly reducing the patients' quality of life. A lowering of the cumulative dose of Paclitaxel can potentially lead to an increased risk of recurrent breast cancer, because the patients have received a lower cumulative dose than the nationally recommended. Cooling gloves and socks cause contractions of blood vessels in hands and feet and reduce blood flow and thus the detrimental effect of chemotherapy on the nerves. No international standard exists for the use of cooling gloves and socks. Eckhoff et al. investigated the risk of CIPN following treatment with Docetaxel, a cytostatic drug similar to Paclitaxel, and aimed at reducing CIPN by the use of cooling gloves and socks. The results showed a significantly lower odds-ratio for development of CIPN at 41%, compared to patients that did not received cooling gloves and socks. The study recommended preventive use of cooling gloves and socks, as the authors saw it as a possible new method to prevent CIPN and indirectly make more patients able to complete the preventive chemotherapy treatment. The aim with the present study is to investigate, if the use of cooling gloves and socks from start of treatment with Paclitaxel, can reduce the risk of CIPN and thus make it possible for the patients to complete the recommended dose per patient of 720 mg/m2. A secondary aim is to investigate to what extent the use of cooling gloves and socks reduces the degree of CIPN.

Description of the cohort

The study consists of two cohorts.

The first cohort is patients that have received preventive treatment for breast cancer in 2016. These patients were offered cooling gloves and socks, only if neuropathy occurred. 

The second cohort is patients that have received the same treatment in 2017, but were offered cooling gloves and socks from the beginning of treatment.

Data and biological material

Informed consent is received from the patients.  Data are collected via reviewing of patient journals.

Collaborating researchers and departments

Master of Science in Public Health, University of Southern Denmark

•  Stud. cand.scient.san. publ. Frederik Rosenbæk

Department of Oncology, Odense University Hospital

• Professor Marianne Ewertz, MD, DMSci
• Consultant Jeanette Dupont Jensen, MD, PhD
• Consultant Hanne Spangsberg Holm, MD