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

NCT03441139 | Terminated

• 1 other identifier: ET17-016 (Cryoanalgesia)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

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.

Conditions

Musculoskeletal Pain

Keywords

Randomized controlled trial; Musculoskeletal metastasis; Cancer pain; Percutaneous cryotherapy; Medical supportive care

Outcome Measures

Primary Outcomes (1)

• 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 from the date of randomization to the date of analgesic strategy failure assessed up to 6 months

Secondary Outcomes (8)

• Percentage of pain relief

  Weekly for the first 3 months, then monthly assessed up to 6 months

• Depth of local pain relief

  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

  Brief Pail Inventory : Monthly assessment up to 6 months

• The impact of local pain on the patient's quality of life

  Monthly assessment up to 6 months

• The impact of local pain on the patient's quality of life

  Monthly assessment up to 6 months

Other Outcomes (3)

• Cost-effectiveness analysis

  Date of last visit (Month 6 +/- 28 days)

• Cost-utility analysis

  Date of last visit (Month 6 +/- 28 days)

• Budget impact analyses

  One-year baseline period. Will be performed in case the experimental strategy dominates the standard strategy

Study Arms (2)

Cryotherapy + medical analgesics

EXPERIMENTAL

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

Other: Cryotherapy + Medical analgesics

Medical analgesics

ACTIVE COMPARATOR

Medical analgesics alone according to the investigator's discretion

Drug: Medical Analgesics

Interventions

Cryotherapy + Medical analgesics 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

Also known as: Percutaneous cryotherapy + Medical analgesics

Cryotherapy + medical analgesics

Medical Analgesics DRUG

Best analgesic therapy at investigator's discretion

Also known as: Best medical medical analgesics

Medical analgesics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (8)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Institut de Cancérologie de Montpellier-Val d'Aurelle

Montpellier, 34298, France

Location

Institut de Cancérologie de l'Ouest - Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Paul Strauss

Strasbourg, 67065, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Cancer Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Charles MASTIER, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 22, 2018
• Study Start: July 19, 2018
• Primary Completion: May 30, 2020
• Study Completion: August 30, 2020
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (8)