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Freezing out pain: cryotherapy trial for breast cancer patients

NCT ID NCT05315011

Symptom relief Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if whole-body cryotherapy (brief exposure to extreme cold) can reduce joint pain caused by aromatase inhibitors, a common hormone therapy for breast cancer. About 70 women will be randomly assigned to either a real or placebo cryotherapy session. Researchers will measure pain levels, quality of life, and painkiller use over 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arthralgia breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aromatase inhibitors Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Montpellier

    Montpellier, 34295, France

  • CHU de Nîmes

    Nîmes, 30029, France

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