Clinical Trial: Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparable Investigation of One Fraction Radiotherapy (8 Gy x 1) and Multifraction Radiotherapy (3 Gy x 10) of Painful Bone Destructions in Patients With Multiple Myeloma.
Brief Summary: Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and recalcification for patients with painful bone metastases from solid tumors. The role of different palliative radiotherapeutic regimens for MM is not well established due to lack of clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.
Detailed Summary:
The primary aim of our prospective study is to analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, the secondary aim is to analyzed the effect of two different radiotherapeutic regimens in the analgesics consumption and recalcification.
Eligibility criteria are age more than 18 years, Karnofsky index more than 40%, patients with painful bone destructions, patients with impending fracture in the region of destructions.
Exclusion Criteria are: patients with bone metastases from solid tumors, patients with solitary plasmacytoma, patients who had received previous irradiation to the present painful destruction site, patients who were incapable to complete the quality of life questionnaires, patients with poor health status.
Sponsor: Lithuanian University of Health Sciences
Current Primary Outcome: To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens. [ Time Frame: At admission and after 4, 12 and 24 weeks after radiotherapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To analyzed the analgesics consumption in two different radiotherapeutic regimens arms. [ Time Frame: At admission and after 4, 12 and 24 weeks after radiotherapy ]
Original Secondary Outcome: Same as current
Information By: Lithuanian University of Health Sciences
Dates:
Date Received: December 19, 2013
Date Started: September 2011
Date Completion: June 2015
Last Updated: December 28, 2013
Last Verified: December 2013
