Clinical trial NCT05825547: Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy
Official title: Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: cryotherapy
cytotoxicity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines.

In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy.

The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent
* The patient must be a member or beneficiary of a health insurance plan
* Patient with metastatic breast cancer with painful subcutaneous metastases.
* Patient eligible for cryotherapy.
* Therapeutic decision of antalgic and palliative treatment by cryotherapy taken in Pluridisciplinary Consultation Meeting.
* Patient available for 15-day follow-up.

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The subject us unable to express their consent or refuses to sign the consent form
* The patient is under safeguard of justice or state guardianship

Primary outcomes:
measure: Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment
timeFrame: Day 0
measure: Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment
timeFrame: Day 15
Secondary outcomes:
measure: Patients' tolerance to cryotherapy treatment
timeFrame: Day 15
measure: Level of pain related to subcutaneous metastases before cryotherapy treatment
timeFrame: Day 0 immediately before cryotherapy treatment
measure: Level of pain related to subcutaneous metastases after cryotherapy treatment
timeFrame: Day 0 immediately after cryotherapy treatment
measure: Level of pain related to subcutaneous metastases after cryotherapy treatment
timeFrame: Day 15
measure: Pain related to subcutaneous metastases before cryotherapy treatment
timeFrame: Day 0 immediately before cryotherapy treatment
measure: Pain related to subcutaneous metastases after cryotherapy treatment
timeFrame: Day 0 immediately after cryotherapy treatment
measure: Pain related to subcutaneous metastases after cryotherapy treatment
timeFrame: Day 15
measure: Patient reported quality of before cryotherapy treatment
timeFrame: Day 0
measure: Patient reported quality of after cryotherapy treatment
timeFrame: Day 15
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU de Nimes
name: Julien Frandon
role: PRINCIPAL_INVESTIGATOR
References: