Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

NCT00712712 | Completed Phase 2 Results

• 4 other identifiers: IB-2007-16IB-MEDORINCA-RECF04982007-002686-13
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases. PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

Conditions

Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

bone metastases; unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)

  Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.

  2 months after radiofrequency ablation (RFA)

Secondary Outcomes (22)

• Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation

  Inclusion and 2 months after radiofrequency ablation (RFA)

• Intensity of Pain (Minimum, Average, Maximum)

  First algology assessment at pre-selection visit

• Intensity of Pain (Minimum, Average, Maximum)

  Second algology assessment at inclusion visit

• Intensity of Pain (Minimum, Average, Maximum)

  Algology assessment one day before radiofrequency (J-1)

• Intensity of Pain (Minimum, Average, Maximum)

  Algology assessment one day after radiofrequency: J+1

Study Arms (1)

Patient who has undergone radiofrequency ablation of bone metastases

EXPERIMENTAL

Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.

Drug: Acetaminophen; Drug: Morphine Sulfate; Other: Questionnaire administration; Procedure: Quality-of-life assessment; Procedure: Radiofrequency ablation

Interventions

Acetaminophen DRUG

Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

Also known as: Paracetamol

Patient who has undergone radiofrequency ablation of bone metastases

Morphine Sulfate DRUG

Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.

Also known as: Oral morphine equivalent

Patient who has undergone radiofrequency ablation of bone metastases

Questionnaire administration OTHER

Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on : * The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital, * the background morphine analgesic treatment during the last 24 hours, * the morphine analgesic treatment taken during painful attacks, * the possible undesirable effects of morphine treatment. * the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent

Patient who has undergone radiofrequency ablation of bone metastases

Quality-of-life assessment PROCEDURE

Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.

Patient who has undergone radiofrequency ablation of bone metastases

Radiofrequency ablation PROCEDURE

Recent technique of thermal destruction of tumors. This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser). Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Patient who has undergone radiofrequency ablation of bone metastases

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed cancer * Primary or unknown origin * Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy * Bone metastases may have been treated with bisphosphonates * Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria: * Lesion size ≤ 5 cm * No more than 2 painful bone metastases * If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time * Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed * Pain located at the tumor or in the area * Maximum pain in the last 24 hours \> 4 points (numerical scale to 11 points) PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * Platelet count \> 50,000/μL * Prothrombin \< 50% * Activated cephalin time ≤ 1.5 times normal * Not pregnant * Fertile patients must use effective contraception * No geographical, social, or psychiatric reason that would preclude follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * At least 3 weeks since prior chemotherapy or bisphosphonates * At least 1 week since beginning new painkiller therapy or anticoagulation treatment * More than 30 days since participation in another drug study * More than 30 days since prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institute Bergonié

Bordeaux, 33076, France

Location

Related Links

• National Cancer Institute
• KUSAJILI

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Acetaminophen; Morphine; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Jean Palussière
• Organization: Institute Bergonie

j.palussiere@bordeaux.unicancer.fr

05 56 33 37 50

Study Officials

• Florence Dixmerias, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 10, 2008
• Study Start: December 24, 2007
• Primary Completion: February 11, 2016
• Study Completion: March 16, 2016
• Last Updated: August 29, 2025
• Results First Posted: March 26, 2021

Record last verified: 2021-03

Locations

FR (1)