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Completed

NCT Number: NCT03374592

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

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.

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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Radiation Injuries Radiotherapy Side Effect Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself
  • Capable of providing the full list of analgesic medication being used
  • Capable of completing the SF-BPI and EORTC questionnaires without any help
  • Life expectancy of at least 3 month
  • KPS greater or equal to 50
  • Radiotherapy to 1 site pain
  • Site of treatment not previously irradiated
  • No planned changes in analgesic within 7 days before and after treatment
  • Patient may be started on Dexamethasone on the first day of radiotherapy
  • No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment
  • Patient provided informed consent to participate in this study

Exclusion criteria

  • 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.
  • Treatment to upper and lower limb
  • Treatment to 2 or more sites of pain
  • Re-irradiation of the site of treatment
  • Women who are pregnant
  • Life expectancy less than 3 month

Treatment and study plan

Volumetric Intensity-Modulated Arc Therapy

Radiation

Advanced radiotherapy technique

Other names: Intensity modulated radiotherapy

Conventional radiotherapy

Radiation

Conventional radiotherapy technique

Primary outcomes

  1. Quality of Life (QOL)

    Time frame: 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 outcomes

  1. Quality of Life - Function subscales

    Time frame: 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.

  2. Quality of Life - Symptom subscales

    Time frame: 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.

  3. Pain relief

    Time frame: 1 week

    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  4. Pain relief

    Time frame: 1 month

    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  5. Pain relief

    Time frame: 3 month

    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  6. Toxicities

    Time frame: 1 week

    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

  7. Toxicities

    Time frame: 1 month

    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

  8. Toxicities

    Time frame: 3 month

    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

Other outcomes

  1. Resource utilization

    Time frame: Baseline

    Time spent in planning and delivering radiotherapy

  2. Physical activity

    Time frame: 1 week

    Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker

  3. Blood biomarkers

    Time frame: 1 week

    Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy

  4. Blood biomarkers

    Time frame: 1 week

    Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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