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

NCT05315011 | Suspended DMC

• 2 other identifiers: RECHMPL20_06142021-A02372-39
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Breast Cancer; Aromatase Inhibitors

Keywords

Aromatase Inhibitor; Arthralgias; Cryotherapy; Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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

• 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

Study Arms (2)

Whole-body cryotherapy

EXPERIMENTAL

The exposure time will be 4 minutes and 30 seconds in -85°C.

Other: Whole-body cryotherapy

Placebo cryotherapy

PLACEBO COMPARATOR

The patient will be placed in a -85°C chamber for 1 minute as part of the placebo treatment.

Other: Placebo cryotherapy

Interventions

Whole-body cryotherapy OTHER

The term "cryotherapy" refers to the process of chilling the body for medicinal purposes. WBC is carried out in a dedicated temperature and humidity controlled cryogenic chamber, which includes a brief exposure to extremely cold air. To avoid frostbite, only a few layers of clothes will be worn during the exposure. To avoid skin burns and necrosis, each participant must first remove their sweat before entering the cryochamber and a surgical mask is also worn to prevent moist air from being exhaled. Subjects will move their fingers and legs in the cryochamber and avoid holding their breath. The exposure time will be 4 minutes and 30 seconds in -85°C.

Whole-body cryotherapy

Placebo cryotherapy OTHER

The patient will be placed in a -85°C chamber for 1 minute as part of the placebo treatment.

Placebo cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Infectious state
• Inflammatory, neurological or metabolic arthropathy
• Fracture or surgery of the painful extremity within the last 6 months
• Concomitant use of corticosteroid therapy
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• CryoMed Millenaire: collaborator

Study Sites (2)

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

• Duraes M, Garbay M, Ferrer C, Duflos C, Rathat G. Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial. BMJ Open. 2023 Dec 9;13(12):e071756. doi: 10.1136/bmjopen-2023-071756.

  PMID: 38070928 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha DURAES, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 7, 2022
• Study Start: May 5, 2023
• Primary Completion: May 4, 2026
• Study Completion (Estimated): May 4, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)