Neoplasms

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Peripheral Nervous System Diseases

Breast Diseases

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Paclitaxel

Albumin-Bound Paclitaxel

Single group, same patient, Homolateral wearing of cryotherapy devices only on hands and feet

Single group, same patient, Homolateral wearing of cryotherapy and compression devices on hands and feet

Self-controlled trial with only standard cryotherapy. Compression glove and foot sock will only be worn on one hand and one leg on the same side allocated by randomisation

cryotherapy alone of the upper or lower limbs

Self-controlled trial adding compression to standard cryotherapy. Compression glove and foot sock will only be worn on one hand and one leg on the same side allocated by randomisation

cryotherapy and crompression of the upper or lower limbs

Colin DEBAIGT, PhD

Clément DEVIC, PhD

Caroline BAILLEUX

Breast cancer is the most frequently diagnosed cancer in the world. In France, 58,000 new cases were detected in 2018. Breast cancer is therefore the most common cancer in women. The 5-year survival rate for all stages combined is 88%. These excellent survival figures have been achieved thanks to improvements in treatment, including the advent of chemotherapy. The majority of patients will be cured of their cancer, so post-cancer quality of life is a major issue, hence the importance of trying to reduce long-term sequelae.

Taxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer. However, taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy (CIPN). The mechanisms of NPIC by taxanes are not fully understood. CINP is manifested by symptoms of paresthesia, numbness, burning, pain, altered temperature perception, myalgia, myopathy, fine motor difficulties, gait and balance disturbances, muscle weakness in the lower limbs and/or functional decline.

NPIC occurs in 80 to 97% of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration. NPIC often leads to postponement or reduction of dose, or even discontinuation of treatment. In addition, NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae. This can promote and/or exacerbate symptoms of psychological distress (depressive symptoms and symptoms of anxiety) and lead to a reduction in quality of life (QoL). Prevention of NIPC is therefore a major issue in breast cancer treatment. According to the 2014 guidelines from the American Society of Clinical Oncology, prevention and treatment of IPN are inadequate with current weapons, and there is an urgent need to evaluate and find new methods of prevention. One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents.

In recent years, the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves (SG) in preventing taxane-induced PINC has been reported. During chemotherapy, patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously. Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion. The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage, or mechanotransduction, and allow a reduction in NIPC.

To date, no study has investigated the efficacy of combining the two means of prevention. The current standard at the Centre Antoine Lacassagne is cryotherapy. The aim of this prospective, self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer.

Open-label, single-centre, randomised (1:1), stratified, self-controlled cohort study

Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy

Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing the Development of Paclitaxel-induced Peripheral Neuropathy in Non-metastatic Breast Cancer: A Prospective, Single-centre, Self-controlled Trial

The limb with the highest grade of neuropathy will be given a score of 1 and the limb with the lowest grade of neuropathy a score of 0. If no neuropathy is identified in either of the 2 limbs, a score of 0 will be given for each limb. Finally, if a neuropathy of the same grade is identified in each of the 2 limbs, a score of 1 will be assigned for both limbs.

Success is defined as a differential of -1 in neuropathy score in favour of double prevention. This method will be applied to the primary and secondary endpoints.

Rate of discontinuation of cryotherapy during treatment

Comparison of the temperature measured between the upper and lower limbs (at extremity level) using an infrared thermometer

Percentage of patients with peripheral neuropathy for any limb according to the results of the DN4 questionnaire just before each treatment cycle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy	NCT06400849	Non-metastatic ...	cryotherapy alo... cryotherapy and...	18 Years - 99 Years	Centre Antoine Lacassagne
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy	NCT06400849	Non-metastatic ...	cryotherapy alo... cryotherapy and...	18 Years - 99 Years	Centre Antoine Lacassagne

Spots Global Cancer Trial Database for cryotherapy alone of the upper or lower limbs