Neoplasm Metastasis, Pain, Quality of Life, Radiotherapy Side Effect
Conditions
Keywords
Intensity-modulated radiation therapy, Volumetric intensity-modulated arc therapy, Radiotherapy, Pain, Metastasis, Quality of Life, Acute Toxicity
Brief summary
This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.
Detailed description
Radiotherapy to painful sites of metastasis can provide pain relief. Side-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation. Volumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation. This study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.
Interventions
RADIATIONVolumetric Intensity-Modulated Arc Therapy
Advanced radiotherapy technique
RADIATIONConventional Radiotherapy
Conventional radiotherapy technique
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself 2. Capable of providing the full list of analgesic medication being used 3. Capable of completing the SF-BPI and EORTC questionnaires without any help 4. Life expectancy of at least 3 month 5. KPS greater or equal to 50 6. Radiotherapy to 1 site pain 7. Site of treatment not previously irradiated 8. No planned changes in analgesic within 7 days before and after treatment • Patient may be started on Dexamethasone on the first day of radiotherapy 9. No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment 10. Patient provided informed consent to participate in this study
Exclusion criteria
1. Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up. 2. Treatment to upper and lower limb 3. Treatment to 2 or more sites of pain 4. Re-irradiation of the site of treatment 5. Women who are pregnant 6. Life expectancy less than 3 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) | 1 week | The global QOL subscale will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. The global QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). Higher scores represent better global QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Symptom subscales | 3 month | Quality of life symptom subscales (dyspnea, pain, fatigue, appetite loss, nausea, constipation, and diarrhea symptoms) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For symptom subscales, higher scores represent worse symptoms. |
| Quality of Life - Function subscales | 3 month | Quality of life function subscales (physical, role, cognitive, emotional, social and financial functions) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For function subscales, higher scores represent better function. |
| Pain relief | 1 week | Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions |
| Toxicities | 1 week | Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarkers | 1 week | Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy |
| Physical activity | 1 week | Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker |
| Resource utilization | Baseline | Time spent in planning and delivering radiotherapy |
Outcome results
None listed