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

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

Interventions

OTHER

Whole-body cryotherapy

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.

OTHER

Placebo cryotherapy

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

Sponsors & Collaborators

• CryoMed Millenaire

  collaborator UNKNOWN

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Martha DURAES, MD · Montpellier University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-05

Primary Completion

2026-05-04

Completion

2027-05-04

Countries

• France

Study Locations