Status:
SUSPENDED
Assessment of Cryotherapy's Analgesic Impact in Anti-aromatase-induced Arthralgia
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
CryoMed Millenaire
Conditions:
Breast Cancer
Aromatase Inhibitors
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 suf...
Detailed Description
In 2018, the number of new cases of breast invasive cancer in France was estimated to be over 58 500, with a median age at diagnosis of 63 years. The 5-year survival rate (as measured by age) has imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 4 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05315011
Start Date
May 5 2023
End Date
May 4 2027
Last Update
December 3 2025
Active Locations (2)
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1
CHU de Montpellier
Montpellier, France, 34295
2
CHU de Nîmes
Nîmes, France, 30029