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

Institut Bergonié

Status and phase: Completed; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00712712

IB-2007-16 (Other Identifier)

IB-MEDOR (Other Identifier)

INCA-RECF0498 (Other Grant/Funding Number)

2007-002686-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

• Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.

Secondary

• Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.
• Determine disease progression by CT scan of bone.
• Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.
• Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate therapy.

OUTLINE: This is a multicenter study.

Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.

Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.

Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.

Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.

Enrollment: 78 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Patient who has undergone radiofrequency ablation of bone metastases

Experimental group

Description:

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.

Treatment:

Other: Questionnaire administration

Drug: Morphine Sulfate

Procedure: Radiofrequency ablation

Procedure: Quality-of-life assessment

Drug: Acetaminophen