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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of whole-body cryotherapy (a treatment that involves exposure to very cold temperatures) on pain relief for women with breast cancer who are experiencing joint pain due to anti-aromatase medication. The trial compares the effects of actual cryotherapy to a placebo treatment (where the procedure is done but without the cold exposure) over a period of 6 weeks. Researchers want to see how well cryotherapy helps reduce pain, improve quality of life, and decrease the need for pain medications.

To be eligible for the trial, participants must be postmenopausal women who have been diagnosed with breast cancer and are currently receiving anti-aromatase treatment for at least 6 months. They should also be experiencing joint pain that has worsened since starting their medication. Participants will undergo 10 cryotherapy sessions over about 2-3 weeks. Throughout the study, their pain levels and quality of life will be assessed using questionnaires. Additionally, the researchers will monitor how well participants tolerate the treatment and any side effects they may experience. This study aims to provide valuable information on whether cryotherapy can help improve the comfort and well-being of women undergoing breast cancer treatment.

Gender

FEMALE

Eligibility criteria

• 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