Clinical trial NCT03441139: Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Randomized controlled trial
Musculoskeletal metastasis
Cancer pain
Percutaneous cryotherapy
Medical supportive care
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Time to analgesic strategy failure
timeFrame: Time from the date of randomization to the date of analgesic strategy failure assessed up to 6 months
Secondary outcomes:
measure: Percentage of pain relief
timeFrame: Weekly for the first 3 months, then monthly assessed up to 6 months
measure: Depth of local pain relief
timeFrame: 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
measure: Depth of local pain relief
timeFrame: Brief Pail Inventory : Monthly assessment up to 6 months
measure: The impact of local pain on the patient's quality of life
timeFrame: Monthly assessment up to 6 months
measure: The impact of local pain on the patient's quality of life
timeFrame: Monthly assessment up to 6 months
measure: Description of analgesic consumption
timeFrame: Weekly for the first 3 months, then monthly assessed up to 6 months
measure: Overall Survival
timeFrame: From date of randomization to date of death from any cause or date of LPLV (estimated date: March 2020)
measure: Tolerance profile
timeFrame: Date of last visit (Month 6 +/- 28 days)
Other outcomes:
measure: Cost-effectiveness analysis
timeFrame: Date of last visit (Month 6 +/- 28 days)
measure: Cost-utility analysis
timeFrame: Date of last visit (Month 6 +/- 28 days)
measure: Budget impact analyses
timeFrame: One-year baseline period. Will be performed in case the experimental strategy dominates the standard strategy
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier-Val d'Aurelle
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau
city: Strasbourg
country: France
facility: Institut Paul Strauss
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Leon Berard
name: Charles MASTIER, MD
role: PRINCIPAL_INVESTIGATOR
References: