Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Neoplasm Metastasis

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Pain

Musculoskeletal Pain

Neoplastic Processes

Muscular Diseases

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

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

Medical analgesics alone according to the investigator's discretion

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

Cryotherapy + Medical analgesics

Best analgesic therapy at investigator's discretion

Medical Analgesics

Charles MASTIER, MD

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.

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.

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

Randomized Controlled Multicenter Prospective Open-label Study of the Efficacy of the Percutaneous Cryotherapy Combined or Not With a Medical Analgesia in the Treatment of Patients With Uncontrolled Painful Musculoskeletal Metastasis

All the resources consumption will be collected during the 6-months timeframe: Hospitalization costs (outpatient, inpatient, and home care), external consultations and wider examinations (eg MRI), transportation costs.

Quantication of financial consequences of rolling out the innovative strategy throughout the health system (i.e. the replacement of Medical supportive care by Medical supportive care + Percutaneous cryotherapy)

Failure will be defined as at least, one of the following situations: Reescalation of the mean local pain by 2 points or more from the lowest pain score from baseline; Absence of pain relief ≥ 2 points 3 months after randomization; Indication of any other loco regional analgesic procedure (radiotherapy, interventional radiology or surgery).

Percentage of pain relief from baseline, rated by patients

Evaluation using the numeric rating scale

Evaluation using the Brief Pain Inventory

Using the EuroQOL-5Dimensions-5Levels questionnaire

Using a booklet completed by the patients and/or the investigator

Time from the date of randomization to the date of death due to any cause

Tolerance assessed according to the NCI-CTC AE version 4

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis	NCT03441139	Musculoskeletal...	Cryotherapy + M... Medical Analges...	18 Years -	Centre Leon Berard
Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis	NCT03441139	Musculoskeletal...	Cryotherapy + M... Medical Analges...	18 Years -	Centre Leon Berard

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