Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01248585
First received: November 22, 2010
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

This research is being done because is is not known if dexamethasone can prevent pain flare (their pain temporarily gets worse before it gets better) caused by the radiation used to treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied in a few people and seems promising, but it is not clear if it can decrease the pain or prevent the pain flare before it happens.


Condition Intervention Phase
Bone Metastases
Drug: Dexamethasone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Pain Flare Incidence [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Reduction in incidence of radiation-induced pain flare from the time of radiotherapy treatment to ten days after the completion of treatment


Secondary Outcome Measures:
  • Pain Flare Incidence [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Reduction in incidence of radiation-induced pain flare from the time of radiotherapy treatment to five days after the completion of treatment

  • Pain Flare Incidence [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Reduction in incidence of radiation-induced pain flare from Day 6 to Day 10 after radiotherapy treatment

  • Pain Score [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Change in median pain score over ten days

  • Analgesic Use [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Change in median analgesic use over ten days

  • Response six weeks after radiation treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response to radiation treatment at six weeks after treatment

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Adverse events

  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Quality of life

  • QoL Validation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Validation of the EORTC QLQ-BM22 (Bone Metastases) module


Estimated Enrollment: 298
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
2 x 4 mg dexamethasone tablets taken once daily for 5 days
Drug: Dexamethasone
2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days
Placebo Comparator: Placebo
2 placebo tablets taken once daily for 5 days
Drug: Placebo
2 placebo tablets taken once daily for 5 days
Other Name: Sugar pill

Detailed Description:

Previous research has shown that for patients who receive radiation therapy to treat their painful bone metastases, about 2 out of every 5 patients (about 40%) experience pain flare. The purpose of this study is to find out whether pain flare is prevented by receiving 8mg dexamethasone at least one hour prior to radiotherapy and once daily for the following 4 days. To do this, half of the patients in this study will get dexamethasone and the other half will receive a placebo (a substance that does not do anything). Using a placebo is the best way to see if a new therapy is effective and to clearly see the potential side effects and impact on quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a histologically or cytologically proven malignancy. All non-hematologic malignant tumours of any histology are eligible.
  • Be 18 years of age or older at the time of randomization.
  • Have bone metastasis(es) corresponding to the clinically painful area(s) documented by radiological imaging within six months prior to randomization.
  • Karnofsky Performance Status (KPS) must be ≥ 40 at the time of the baseline evaluation (within seven days prior to randomization). As it is difficult to obtain complete data from inpatients on a daily basis, they should not be randomized to this study.
  • Is planned to receive palliative radiotherapy to one or two bony metastasis(es) with the treatment given as 8 Gy in a single fraction to all sites to be followed for the study. Although a maximum of two sites can be treated and followed for the study, patients with more than two skeletal metastases are eligible. At the time of delivery of study radiotherapy, only the site(s) being followed for the study may be treated.
  • Is able to provide the worst pain score at the bony metastatic site(s) planned for palliative radiotherapy.
  • Has a baseline worst pain score ≥ 2 on a scale of 0-10 at all the bony metastatic site(s) planned for palliative radiotherapy as part of this study within 7 days prior to randomization. If two painful sites will be followed for the study, this requirement must be met on the same day for both sites.
  • Is able and willing to fill out the daily diary.
  • Is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or French. The baseline assessment must be completed within required timelines prior to randomization. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is provided. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records.
  • If being enrolled through a centre participating in the correlative science component of the study, is willing and able to provide a pre- and post-treatment urine sample. Language pertaining to patient consent for urine collection must be included in the consent form for the main study at these centres. The patient must sign this consent form prior to collection of the first urine sample.
  • If being enrolled through a centre participating in the correlative science component of the study, patient consent for the saliva collection component of the trial must be obtained in the same manner as outlined above for the main study consent. The patient must sign the saliva collection Informed Consent form.
  • Must be accessible for treatment and follow-up. Investigators must be reasonably assured that the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Protocol treatment is to begin within one week of patient randomization.

Exclusion Criteria:

  • Patients with hematologic malignancies (leukemia, Hodgkin's or non-Hodgkin's lymphoma or plasma cell dyscrasia, including multiple myeloma) are ineligible as steroids constitute anti-cancer therapy for these malignancies.
  • Concurrent use or use within previous seven days of any corticosteroid medication other than topical or inhaled preparations. Patients with any type of cancer who are receiving steroids as a component of their systemic therapy are ineligible. Patients requiring steroids for a co-existing medical problem are ineligible. Patients who received a one- to three-day dose of steroids as an antiemetic for chemotherapy treatment are eligible, as long as at least 72 hours have elapsed since the last dose of antiemetic therapy.
  • Medical contraindications to corticosteroids such as uncontrolled diabetes mellitus, uncontrolled hypertension, active peptic ulcer or hypokalemia.
  • Uncorrected hypokalemia that is known to exist within 7 days prior to randomization. Patients with previous hypokalemia that has been corrected are eligible. Hypokalemia is defined as a potassium level < 3.0 mmol/L. Testing of electrolytes, including potassium level, is not a protocol requirement.
  • Random glucose level ≥ 13.9 mmol/L within 7 days prior to randomization.Testing of glucose within 7 days prior to randomization is a protocol requirement. Point of care testing with a glucometer is permissible.
  • Pathological fracture of the femora, tibiae, fibulae, humeri, radii or ulnae at the site(s) to be followed for the study.
  • Radiological evidence of high-risk lesions for pathological fractures in the femora, tibiae, fibulae, humeri, radii or ulnae at the site(s) to be followed for the study (lytic lesions > 3 cm or > 50% cortical erosion of bone diameter).
  • Clinical or available radiologic evidence of spinal cord or cauda equina compression at the site(s) to be followed for the study.
  • Plans to receive palliative radiotherapy to a site or sites other than the one(s) being followed for the study during the ten-day period following study radiotherapy.
  • Planned orthopedic intervention, including kyphoplasty, vertebroplasty or cementoplasty, to any of the site(s) to be followed for the study.
  • Prior palliative surgery to any of the site(s) to be followed for the study.
  • Inability, with available translator assistance, to record pain score and medication consumption in the daily diary and to communicate this to study personnel.
  • Receipt of radiopharmaceutical treatment at any time.
  • Previous external beam radiotherapy (including hemibody radiotherapy) using a field that included the site(s) to be followed for the study.
  • Inability to swallow or tolerate oral medications, e.g. due to intractable nausea and/or emesis.
  • Plans to receive cytotoxic chemotherapy or systemic steroids during the on-study period (day of study radiotherapy and the subsequent ten days).
  • Plans to start or stop systemic therapy other than cytotoxic chemotherapy (e.g. hormonal therapy; immunotherapy; bisphosphonates) during the on-study period (day of study radiotherapy and the subsequent ten days). Patients who are already receiving these types of treatments are eligible as long as no changes are planned during the study period.
  • Regular use of a non-steroidal anti-inflammatory drug (NSAID). Patients must not be taking NSAIDs at randomization and their use during the on-study period (day of study radiotherapy and the subsequent ten days) must not be required or expected. Patients who use daily low-dose ASA for anti-platelet therapy are eligible if ASA has been used for more than one month prior to the time of randomization.
  • Plans for a change in analgesic regimen on the day of randomization.
  • Previous entry on the SC.23 study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248585

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Edward LW Chow Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Study Chair: Carlo De Angelis Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Study Chair: Alysa Fairchild Cross Cancer Institute, Edmonton AB
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01248585     History of Changes
Other Study ID Numbers: SC23
Study First Received: November 22, 2010
Last Updated: May 11, 2015
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
Symptom Control

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on July 26, 2015