Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis

NCT ID: NCT03441139

Last Updated: 2021-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2020-08-30

Brief Summary

The primary objective of this trial is to compare the efficacy of 2 analgesic strategies, based on percutaneous cryotherapy plus medical supportive care versus medical supportive care alone in the treatment of cancer patients with painful musculoskeletal metastasis.

Detailed Description

There is a substantial body of evidences that support the rationale for percutaneous cryotherapy in the treatment of painful musculoskeletal metastasis. Since the available results are based exclusively on retrospective and single-arm prospective studies, all authors agree that preliminary data deserves further investigation to provide high level evidences.

Current knowledge, along with the need for relieving patients' pain, already leads interventional radiologists to introduce analgesic cryotherapy in their routine practice. Our team usually notes a clinically significant pain relief that is immediate, continuous and prolonged in these patients. However, facing the lack of comparative studies, this technique is still proposed to patients with poor life-expectancy.

Percutaneous cryotherapy is an innovative strategy in the treatment of patients with uncontrolled painful metastases. It could provide a significant and durable pain relief and a better quality of life, earlier in the patient's care pathway.

The study group hypotheses that an early procedure of percutaneous cryotherapy is able to provide painful patients with better and prolonged analgesia and quality of life.

A prospective controlled study is proposed with two analgesic strategies (percutaneous cryotherapy plus medical supportive care versus medical supportive care alone) in patients with a painful metastasis not controlled by conventional analgesia strategy.

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cryotherapy + medical analgesics

Percutaneous Cryotherapy and medical analgesics according to the investigator's discretion

Group Type: EXPERIMENTAL

Cryotherapy + Medical analgesics

Intervention Type: OTHER

Percutaneous cryotherapy: A complete cycle of treatment will require 2 freezing 10-minutes periods, separate by a 9-minutes passive and 1-minute active thaw, with the cryoablation system. Dimension of the iceball coverage above the tumor will be monitored by non-contrast CT or MRI during the freezing cycle.

Medical supportive care: Best analgesic therapy at investigator's discretion

Medical analgesics

Medical analgesics alone according to the investigator's discretion

Group Type: ACTIVE_COMPARATOR

Medical Analgesics

Intervention Type: DRUG

Best analgesic therapy at investigator's discretion

Interventions

Cryotherapy + Medical analgesics

Percutaneous cryotherapy: A complete cycle of treatment will require 2 freezing 10-minutes periods, separate by a 9-minutes passive and 1-minute active thaw, with the cryoablation system. Dimension of the iceball coverage above the tumor will be monitored by non-contrast CT or MRI during the freezing cycle.

Medical supportive care: Best analgesic therapy at investigator's discretion

Intervention Type: OTHER

Medical Analgesics

Best analgesic therapy at investigator's discretion

Intervention Type: DRUG

Other Intervention Names

Percutaneous cryotherapy + Medical analgesics; Best medical medical analgesics

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years at the day of consenting to the study;
• Patient with at least 1 painful metastasis with a musculoskeletal involvement;
• Patient referred to a Pain Management Unit to optimize the analgesic strategy;
• Painful metastatic lesion that fulfils with all the following :

• Pain must be correlated with an identifiable lesion on imaging (Computed Tomography, Magnetic Resonance Imaging or Ultrasonography)
• Level of mean pain within the past 24 hours of at least 4/10 (numeric rating scale)
• Painful metastasis suitable for a procedure of percutaneous cryotherapy
• Life-expectancy longer than 6 months;
• Performance Status of the ECOG ≤2;
• Neutrophils count > 1 Gi/l within the past 14 days;
• Adequate coagulation panel (as per the investigator judgement);
• Ability to understand and willingness for follow-up visits;
• Covered by a medical insurance;
• Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.

Exclusion Criteria

• Patient with a primary tumor of leukemia, lymphoma or myeloma;
• Tumor involving a weight bearing long bone of the lower limbs with the tumor causing more than 50% of cortical bone;
• Lesion amenable to any curative intervention;
• Formal indication for local analgesic procedure other than percutaneous cryotherapy;
• Prior radiotherapy on the targeted lesion within the 3 weeks prior to randomization;
• Patient with any contraindication for the procedure of percutaneous cryotherapy, including treatment requiring ice ball formation within 0.5 cm of the spinal cord, brain, other critical nerve, structure, large abdominal vessels such as the aorta or inferior vena cava, bowel or bladder (except if active or passive thermic protection can be performed);
• Uncontrolled coagulopathy or bleeding disorders;
• Evidence of pregnancy, breast-feeding, or patient wishing to become pregnant during the study;
• Active, uncontrolled infection;
• Any cognitive impairment or any disease that may restrain the use of numeric scales and the administration of quality of life questionnaires;
• Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would likely interfere with study procedures or results;
• Concurrent participation in other experimental studies that could interfere with the primary endpoint assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles MASTIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Institut Bergonié

Bordeaux, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Institut de Cancérologie de Montpellier-Val d'Aurelle

Montpellier, , France

Institut de Cancérologie de l'Ouest - Centre René Gauducheau

Saint-Herblain, , France

Institut Paul Strauss

Strasbourg, , France

CHRU de Strasbourg

Strasbourg, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

ET17-016 (Cryoanalgesia)

Identifier Type: -

Identifier Source: org_study_id