Breast Cancer Clinical Trial
— CRYOMATASEOfficial title:
Evaluation of the Analgesic Effect of Cryotherapy in Anti-aromatase-induced Arthralgia: a Prospective Randomized Study
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | February 4, 2026 |
Est. primary completion date | February 4, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Montpellier | Montpellier | |
France | CHU de Nîmes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | CryoMed Millenaire |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The most intense pain | The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF) at baseline (question 3 of 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. |
2 weeks before the first cryotherapy session | |
Primary | The most intense pain | 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. | 6 weeks after the last cryotherapy session | |
Secondary | The most intense pain | The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF) | 3 months and 6 months after the last cryotherapy session | |
Secondary | Pain severity score | The BPI assesses pain severity at its "worst," "least," "average," and "now" (current pain) with the questions 3, 4, 5 and 6. Responses to these 4 items are rated from 0 (No pain) to 10 (Pain as bad as you can imagine). The average of these 4 items is the composite pain interference score. | 6 weeks, 3 months, 6 months after the last cryotherapy session | |
Secondary | Pain interference score | The question 9 of BPI-SF measures how much pain interfered with seven daily activities: general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. These 7 items are measured from 0 (Does not interference) to 10 (Completely interferes). BPI pain interference is scored as the mean of the seven interference items. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration. | 6 weeks, 3 months, 6 months after the last cryotherapy session | |
Secondary | HAQ score | The Health Assessment Questionnaire (HAQ) Each question is given the following score:
0 = without any difficulty = with some difficulty = with great difficulty = unable to do so The rating for each of the 8 domains (dressing, body care, getting up, eating, walking, hygiene, catching, grasping, other activities) is the one corresponding to the highest score of the questions in that domain. If there is missing data for one or more questions in a particular domain, the rating is the highest score of the questions with an answer (missing data is not taken into account). The notion of the need for assistance from a third party and/or the use of devices can modify this scoring system. In this case the score for the domain concerned must be at least equal to 2 (a score of 3 is given if the highest score is equal to 3: in all other cases a score of 2 is given). The functional index is the sum of the scores of the various domains divided by the number of domains assessed (normally 8 |
6 weeks, 3 months, 6 months after the last cryotherapy session | |
Secondary | Number of days of anti-aromatases taken during the 15 days preceding the visit | Number of days of taking anti-aromatase treatment at 6 weeks, 3 and 6 months after cryotherapy. | 6 weeks, 3 months, 6 months after the last cryotherapy session | |
Secondary | Number of analgesics | Use of analgesics taken during the 15 days preceding the visit classified into three categories: stage 1, 2 and 3, at 6 weeks, 3 and 6 months after cryotherapy. | 6 weeks, 3 months, 6 months after the last cryotherapy session |
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