Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Pain Clinical Trial

Official title:

A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374592
• Other study ID #: CE14.046
• Status: Completed
• Phase: N/A
• Start date: July 7, 2014
• Est. completion date: February 21, 2018

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 21, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Neoplasm Metastasis
• Pain
• Quality of Life
• Radiotherapy Side Effect

Intervention

Radiation:
• Volumetric Intensity-Modulated Arc Therapy
Advanced radiotherapy technique
• Conventional Radiotherapy
Conventional radiotherapy technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

References & Publications (2)

Dorion V, Lambert L, Frazzi A, Cayer JF, Wong P. A Pilot Study in the Use of Activity Trackers for Assessing Response to Palliative Radiotherapy. Cureus. 2017 Nov 22;9(11):e1871. doi: 10.7759/cureus.1871. — View Citation

Wong P, Lambert L, Thanomsack P, Coulombe G, Lambert C, Charpentier AM, Barkati M, Fortin I, Lafontaine J, Roberge D. Quality of Life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3-Dimensional Conventional Radiation Therapy. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource utilization	Time spent in planning and delivering radiotherapy	Baseline
Other	Physical activity	Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker	1 week
Other	Blood biomarkers	Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy	1 week
Other	Blood biomarkers	Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy	1 week
Primary	Quality of Life (QOL)	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.	1 week
Secondary	Quality of Life - Function subscales	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.	3 month
Secondary	Quality of Life - Symptom subscales	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.	3 month
Secondary	Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	1 week
Secondary	Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	1 month
Secondary	Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	3 month
Secondary	Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	1 week
Secondary	Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	1 month
Secondary	Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	3 month