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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
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
Best analgesic therapy at investigator's discretion
Institut Bergonié
Bordeaux, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut de Cancérologie de Montpellier-Val d'Aurelle
Montpellier, France
Time to analgesic strategy failure
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).
Time frame: Time from the date of randomization to the date of analgesic strategy failure assessed up to 6 months
Percentage of pain relief
Percentage of pain relief from baseline, rated by patients
Time frame: Weekly for the first 3 months, then monthly assessed up to 6 months
Depth of local pain relief
Evaluation using the numeric rating scale
Time frame: Numeric rating scale (scale range from 0 [no pain] to 10 [worst imaginable pain]): Weekly for the first 3 months, then monthly assessed up to 6 months
Depth of local pain relief
Evaluation using the Brief Pain Inventory
Time frame: Brief Pail Inventory : Monthly assessment up to 6 months
The impact of local pain on the patient's quality of life
Using the FACT-BP questionnaire
Time frame: Monthly assessment up to 6 months
The impact of local pain on the patient's quality of life
Using the EuroQOL-5Dimensions-5Levels questionnaire
Time frame: Monthly assessment up to 6 months
Description of analgesic consumption
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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
Using a booklet completed by the patients and/or the investigator
Time frame: Weekly for the first 3 months, then monthly assessed up to 6 months
Overall Survival
Time from the date of randomization to the date of death due to any cause
Time frame: From date of randomization to date of death from any cause or date of LPLV (estimated date: March 2020)
Tolerance profile
Tolerance assessed according to the NCI-CTC AE version 4
Time frame: Date of last visit (Month 6 +/- 28 days)