Bone MetastasesPhase 3NCT01248585
Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
A Phase 3 study testing Dexamethasone in people with Bone Metastases, run by NCIC Clinical Trials Group at 22 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 22 sitesCanada
- Study dates
- 30 May 2011to 27 Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Canada22 sites
BCCA - Abbotsford Centre
Abbotsford British Columbia, British Columbia, V2S 0C2
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Regional Cancer Program
London, Ontario, N6A 4L6
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, E1C 8X3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
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
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.
Read the 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.
- Conditions
- Bone Metastases
- Being tested
- Dexamethasone, Placebo
- Keywords
- Symptom Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days
PlaceboDrug
Also called Sugar pill
2 placebo tablets taken once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | 2 x 4 mg dexamethasone tablets taken once daily for 5 days Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | 2 placebo tablets taken once daily for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation-induced Pain Flare Incidence
The incidences of radiation-induced pain flare from the time of radiotherapy treatment to ten days after the completion of treatment
Measured: 10 days
Secondary outcomes (4)
Radiation-induced Pain Flare Incidence From Day 6 to Day 10 After Radiotherapy Treatment
Reduction in incidence of radiation-induced pain flare from Day 6 to Day 10 after radiotherapy treatment
Measured: From Day 6 to day 10 after radiotherapy treatment
Analgesic Use
Change in mean analgesic use from baseline to day 10.
Measured: 10 days
Response to Radiation Treatment at Six Weeks
Response to radiation treatment at six weeks after treatment. Complete response (CR) is defined as a worst pain score of zero (0) at the bony metastatic site with no concomitant increase in analgesic intake (stable or reduced oral morphine equivalent dosage (OMED)).
Partial response (PR) is defined as any of the following:
- Reduction in worst pain score of two or more at the bony metastatic site on a 0-10 scale without analgesic increase. ii. Analgesic reduction of 25% or more from baseline without an increase in worst pain score with reference to baseline. iii. For patients who were using opioid analgesics at the baseline assessment, a daily oral morphine equivalence of zero (0) without an increase in worst pain score relative to the baseline worst pain score
Measured: From day 0 to 6 weeks
Change in Pain Intensity Score Over 10 Days After Radiotherapy.
Change in pain score over 10 days after radiotherapy, pain score range from 0 (no pain) to 10 (worst pain as can imagine).
Measured: Pain intensity score change from baseline of day 0 to day 10 after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study start30 May 2011
- Primary completion25 May 2015
- Study completion27 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Edward LW Chow, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ONCarlo De Angelis, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ONAlysa Fairchild, Study chair, Cross Cancer Institute, Edmonton AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248585
- Sponsor's protocol ID
- SC23
- Status last verified
- Apr 2020
- First submitted
- 22 Nov 2010
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chow E, Meyer RM, Ding K, Nabid A, Chabot P, Wong P, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, Brundage M, DeAngelis C, Wong RKS. Dexamethasone in the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases: a double-blind, randomised placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1463-1472. doi: 10.1016/S1470-2045(15)00199-0. Epub 2015 Oct 18.
PubMed 26489389Chow S, Ding K, Wan BA, Brundage M, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Chow E. Gender differences in pain and patient reported outcomes: a secondary analysis of the NCIC CTG SC. 23 randomized trial. Ann Palliat Med. 2017 Dec;6(Suppl 2):S185-S194. doi: 10.21037/apm.2017.08.12. Epub 2017 Aug 29.
PubMed 29156903McDonald R, Ding K, Brundage M, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Chan S, Chow E. Effect of Radiotherapy on Painful Bone Metastases: A Secondary Analysis of the NCIC Clinical Trials Group Symptom Control Trial SC.23. JAMA Oncol. 2017 Jul 1;3(7):953-959. doi: 10.1001/jamaoncol.2016.6770.
PubMed 28196208Raman S, Ding K, Chow E, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Brundage M. Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. Qual Life Res. 2016 Oct;25(10):2535-2541. doi: 10.1007/s11136-016-1308-4. Epub 2016 May 2.
PubMed 27138964
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01248585
- Acronym / sponsor ID
- SC23
- Conditions
- Bone Metastases
- Keywords
- Symptom Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 30 May 2011 (actual)
- Primary completion
- 25 May 2015 (actual)
- Study completion
- 27 Nov 2015 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone2 x 4 mg dexamethasone tablets taken once daily for 5 days |
| Placebo | Placebo comparator | Drug: Placebo2 placebo tablets taken once daily for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days | Drug | Dexamethasone |
| PlaceboAlso: Sugar pill2 placebo tablets taken once daily for 5 days | Drug | Placebo |
Primary outcome
Radiation-induced Pain Flare Incidence
Time frame: 10 days
The incidences of radiation-induced pain flare from the time of radiotherapy treatment to ten days after the completion of treatment
4 secondary outcomes
Radiation-induced Pain Flare Incidence From Day 6 to Day 10 After Radiotherapy Treatment
Time frame: From Day 6 to day 10 after radiotherapy treatment
Analgesic Use
Time frame: 10 days
Response to Radiation Treatment at Six Weeks
Time frame: From day 0 to 6 weeks
Change in Pain Intensity Score Over 10 Days After Radiotherapy.
Time frame: Pain intensity score change from baseline of day 0 to day 10 after radiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26489389Chow E, Meyer RM, Ding K, Nabid A, Chabot P, Wong P, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, Brundage M, DeAngelis C, Wong RKS. Dexamethasone in the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases: a double-blind, randomised placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1463-1472. doi: 10.1016/S1470-2045(15)00199-0. Epub 2015 Oct 18.
- Derived from this study: PubMed 29156903Chow S, Ding K, Wan BA, Brundage M, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Chow E. Gender differences in pain and patient reported outcomes: a secondary analysis of the NCIC CTG SC. 23 randomized trial. Ann Palliat Med. 2017 Dec;6(Suppl 2):S185-S194. doi: 10.21037/apm.2017.08.12. Epub 2017 Aug 29.
- Derived from this study: PubMed 28196208McDonald R, Ding K, Brundage M, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Chan S, Chow E. Effect of Radiotherapy on Painful Bone Metastases: A Secondary Analysis of the NCIC Clinical Trials Group Symptom Control Trial SC.23. JAMA Oncol. 2017 Jul 1;3(7):953-959. doi: 10.1001/jamaoncol.2016.6770.
- Derived from this study: PubMed 27138964Raman S, Ding K, Chow E, Meyer RM, Nabid A, Chabot P, Coulombe G, Ahmed S, Kuk J, Dar AR, Mahmud A, Fairchild A, Wilson CF, Wu JSY, Dennis K, DeAngelis C, Wong RKS, Zhu L, Brundage M. Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. Qual Life Res. 2016 Oct;25(10):2535-2541. doi: 10.1007/s11136-016-1308-4. Epub 2016 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward LW Chow study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Carlo De Angelis study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Alysa Fairchild study chair
Cross Cancer Institute, Edmonton AB
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Bone Metastases, run by NCIC Clinical Trials Group at 22 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation-induced Pain Flare Incidence (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248585, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.