Evaluation of the Analgesic Effect of Cryotherapy in Anti-aromatase-induced Arthralgia: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- The most intense pain
研究概览
简要总结
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.
详细描述
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 improved over time thanks to various treatments . Hormonotherapy is one of the disease's treatment options, and it includes a variety of molecules, including aromatase inhibitors. Despite their effectiveness, aromatase inhibitors cause a variety of side effects, including arthralgia in 35 percent to 50% of patients. The physiopathological mechanisms underlying these arthralgies would include articular inflammation, increased intra-articular fluid, and the appearance of a tenosynovitis. These side effects are frequently responsible for the premature discontinuation of hormone therapy and, as a result, the therapeutic effect of molecules. In order to improve the management of arthralgias caused by aromatase inhibitors, and because current recommendations are unclear, the effects of whole-body cryotherapy in patients who are taking an aromatase inhibitor for a hormono-dependent cancer in an adjuvant setting will be investigated. In fact, cryotherapy has already demonstrated its efficacy in the treatment of arthritic pain in a variety of diseases (rheumatoid arthritis,..).
This is a category 1, comparative, randomized, prospective, multicenter study. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group.
Randomization will be performed after information and signature of informed consent on the day of the inclusion visit.
Patients will be randomized to either
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •Patient with stable analgesic treatment for at least 15 days (without dose increase or change in step).
排除标准
- •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
- •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
研究组 & 干预措施
Whole-body cryotherapy
The exposure time will be 4 minutes and 30 seconds in -85°C.
干预措施: Whole-body cryotherapy (Other)
Placebo cryotherapy
The patient will be placed in a -85°C chamber for 1 minute as part of the placebo treatment.
干预措施: Placebo cryotherapy (Other)
结局指标
主要结局
The most intense pain
时间窗: 6 weeks after the last cryotherapy session
The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF) The two domains measured by the BPI-SF pain intensity (severity) and the impact of pain on functioning (interference). It is a pain and quality of life assessment measure used to examine pain intensity (sensory dimension) and functional impact (reactive dimension) in patients. Numerical scales from 0 to 10 indicate overall pain intensity, worst pain, least pain and current pain. A figure representing the human body is included to allow the patient to mark in which part of the body the pain is located.
次要结局
- The most intense pain(3 months and 6 months after the last cryotherapy session)
- Pain severity score(6 weeks, 3 months, 6 months after the last cryotherapy session)
- Pain interference score(6 weeks, 3 months, 6 months after the last cryotherapy session)
- Number of analgesics(6 weeks, 3 months, 6 months after the last cryotherapy session)
- HAQ score(6 weeks, 3 months, 6 months after the last cryotherapy session)
- Number of days of anti-aromatases taken during the 15 days preceding the visit(6 weeks, 3 months, 6 months after the last cryotherapy session)