Musculoskeletal PainCRYONCT03441139
Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis
A study testing Cryotherapy + Medical analgesics and Medical Analgesics in people with Musculoskeletal Pain, run by Centre Leon Berard at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Cryotherapy + Medical analgesics and Medical Analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesFrance
- Study dates
- 19 Jul 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut Bergonié
Bordeaux, 33076
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
Institut de Cancérologie de Montpellier-Val d'Aurelle
Montpellier, 34298
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain, 44805
Institut Paul Strauss
Strasbourg, 67065
CHRU de Strasbourg
Strasbourg, 67091
Institut Gustave Roussy
Villejuif, 94805
About this study
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
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.
Read the 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
- Being tested
- Cryotherapy + Medical analgesics, Medical Analgesics
- Keywords
- Randomized controlled trial, Musculoskeletal metastasis, Cancer pain, Percutaneous cryotherapy, Medical supportive care
- Medical subject headings
- Musculoskeletal Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy + Medical analgesicsOther
Also called Percutaneous 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
Medical AnalgesicsDrug
Also called Best medical medical analgesics
Best analgesic therapy at investigator's discretion
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy + medical analgesics | Experimental | Percutaneous Cryotherapy and medical analgesics according to the investigator's discretion Receives: Other: Cryotherapy + Medical analgesics |
| Medical analgesics | Active comparator | Medical analgesics alone according to the investigator's discretion Receives: Drug: Medical Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Percentage of pain relief from baseline, rated by patients
Measured: Weekly for the first 3 months, then monthly assessed up to 6 months
Depth of local pain relief
Evaluation using the numeric rating scale
Measured: 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
Measured: 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
Measured: Monthly assessment up to 6 months
The impact of local pain on the patient's quality of life
Using the EuroQOL-5Dimensions-5Levels questionnaire
Measured: Monthly assessment up to 6 months
Description of analgesic consumption
Using a booklet completed by the patients and/or the investigator
Measured: 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
Measured: 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
Measured: Date of last visit (Month 6 +/- 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start19 Jul 2018
- Primary completion30 May 2020
- Study completion30 Aug 2020
Why it stopped: Difficulty to recruit patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles MASTIER, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441139
- Sponsor's protocol ID
- ET17-016 (Cryoanalgesia)
- Acronym
- CRYO
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2018
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03441139
- Acronym / sponsor ID
- CRYO / ET17-016 (Cryoanalgesia)
- Conditions
- Musculoskeletal Pain
- Keywords
- Randomized controlled trial, Musculoskeletal metastasis, Cancer pain, Percutaneous cryotherapy, Medical supportive care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit patient.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy + medical analgesics | Experimental | Other: Cryotherapy + Medical analgesicsPercutaneous Cryotherapy and medical analgesics according to the investigator's discretion |
| Medical analgesics | Active comparator | Drug: Medical AnalgesicsMedical analgesics alone according to the investigator's discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 :
- Life-expectancy longer than 6 months;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy + Medical analgesicsAlso: Percutaneous cryotherapy + Medical analgesicsPercutaneous 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 | Other | Cryotherapy + medical analgesics |
| Medical AnalgesicsAlso: Best medical medical analgesicsBest analgesic therapy at investigator's discretion | Drug | Medical analgesics |
Primary outcome
Time to analgesic strategy failure
Time frame: Time from the date of randomization to the date of analgesic strategy failure assessed up to 6 months
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).
8 secondary outcomes
Percentage of pain relief
Time frame: Weekly for the first 3 months, then monthly assessed up to 6 months
Depth of local pain relief
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
Time frame: Brief Pail Inventory : Monthly assessment up to 6 months
The impact of local pain on the patient's quality of life
Time frame: Monthly assessment up to 6 months
The impact of local pain on the patient's quality of life
Time frame: Monthly assessment up to 6 months
Description of analgesic consumption
Time frame: Weekly for the first 3 months, then monthly assessed up to 6 months
Overall Survival
Time frame: From date of randomization to date of death from any cause or date of LPLV (estimated date: March 2020)
Tolerance profile
Time frame: Date of last visit (Month 6 +/- 28 days)
Results and safety
The study was stopped early (reason given: Difficulty to recruit patient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles MASTIER, MD principal investigator
Centre Leon Berard
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy + Medical analgesics and Medical Analgesics in people with Musculoskeletal Pain, run by Centre Leon Berard at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty to recruit patient.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to analgesic strategy failure (time frame: Time from the date of randomization to the date of analgesic strategy failure assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.