Assessment of Cryotherapy's Analgesic Impact in Anti-aromatase-induced Arthralgia

The first aim of this comparative, randomized, prospective, multicenter study is to evaluate the analgesic effect at 6 weeks of whole-body cryotherapy, compared to placebo cryotherapy, in patients suffering from arthralgia under aromatase inhibitor treatment for hormone-dependent breast cancer in adjuvant situation. The secondary objectives are to evaluate the tolerance of cryotherapy sessions and the evaluation of the impact of the cryotherapy sessions on the consumption of analgesics, the compliance of the treatment by anti-aromatases, the quality of life. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group: * Whole Body Cryotherapy group (Arm A), or * Placebo Cryotherapy group (Arm B). Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent. The sessions will be performed according to the randomization arm as follows * Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds. * Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute. Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit. Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit. Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit). The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Major non-menopausal patient
* Patient managed for histologically proven breast cancer
* Patient undergoing adjuvant anti-aromatase treatment (letrozole, anastrozole or exemestane) for at least 6 months
* Patient with arthralgias affecting one or more joints that have occurred or been exacerbated since the anti-aromatase treatment
* Patient with a score for the most severe pain experienced in the last week on the Brief Pain Inventory-Short Form (BPI-SF) ≥ 3.
* Patient with stable analgesic treatment for at least 15 days (without dose increase or change in step).

Exclusion Criteria:

* Infectious state
* Inflammatory, neurological or metabolic arthropathy
* Fracture or surgery of the painful extremity within the last 6 months
* Concomitant use of corticosteroid therapy
* Treatment with cryotherapy within 6 months prior to study inclusion
* Uncontrolled hypertension / Known coronary artery disease / History of myocardial infarction / History of cardiac rhythm disorder / Valvulopathy
* Pacemaker
* Previous venous thromboembolic event in progress
* Stage 3-4 arterial disease
* Unregulated hypothyroidism
* Severe Raynaud's syndrome
* Cryoglobulinemia
* Chronic respiratory insufficiency
* Polyneuropathy
* Acute renal or urinary pathology
* Epilepsy
* Alcohol and/or drug abuse
* Healing disorders
* Known allergy to cold
* Claustrophobia
* Uncontrolled hyperhydrosis
* Patient participating in another interventional research involving the human being
* Patient deprived of liberty by judicial or administrative decision.
* Patient protected by law under guardianship or curatorship
* Failure to obtain free, informed and written consent after a period of reflection
* Patient not affiliated or beneficiary of a national health insurance system

• BACKGROUNDDuraes M, Garbay M, Ferrer C, Duflos C, Rathat G. Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial. BMJ Open. 2023 Dec 9;13(12):e071756. doi: 10.1136/bmjopen-2023-071756. PMID 38070928