Evaluating cryotherapy for pain relief in breast cancer patients on aromatase inhibitors
Evaluation of the Analgesic Effect of Cryotherapy in Anti-aromatase-induced Arthralgia: a Prospective Randomized Study
This study is testing if whole-body cryotherapy can help relieve joint pain in breast cancer patients who are taking aromatase inhibitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT05315011 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, and prospective study aims to assess the analgesic effects of whole-body cryotherapy compared to placebo in patients experiencing arthralgia due to aromatase inhibitor treatment for hormone-dependent breast cancer. The study will evaluate pain relief over six weeks, as well as the tolerance of cryotherapy sessions and their impact on analgesic consumption and quality of life. Both patients and investigators will be blinded to the treatment allocation, ensuring unbiased results. The study seeks to improve management strategies for arthralgia associated with breast cancer treatments.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women with histologically confirmed breast cancer who are currently on adjuvant aromatase inhibitor treatment and experiencing joint pain.
Not a fit: Patients with inflammatory or neurological arthropathies, recent fractures, or those on corticosteroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective non-pharmacological treatment option for pain relief in breast cancer patients undergoing aromatase inhibitor therapy.
How similar studies have performed: Previous studies have shown cryotherapy to be effective in treating arthritic pain in various conditions, suggesting potential success for this approach in the current context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier and 1 other locations
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Martha DURAES, MD — Montpellier University Hospital
- Study coordinator: Martha DURAES, MD
- Email: m-duraes@chu-montpellier.fr
- Phone: +334.67.33.65.32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.