Trial Outcomes & Findings for Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases (NCT NCT01248585)

NCT ID: NCT01248585

Last Updated: 2023-08-28

Results Overview

The incidences of radiation-induced pain flare from the time of radiotherapy treatment to ten days after the completion of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 298 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2023-08-28

Participant Flow

Participant milestones

Measure	Dexamethasone 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Overall Study STARTED	148	150
Overall Study COMPLETED	148	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dexamethasone n=148 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=150 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days	Total n=298 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	68.6 years STANDARD_DEVIATION 12 • n=7 Participants	67.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	68 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants
Region of Enrollment Canada	148 participants n=5 Participants	150 participants n=7 Participants	298 participants n=5 Participants
Primary cancer site Breast	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants
Primary cancer site Lung	41 participants n=5 Participants	39 participants n=7 Participants	80 participants n=5 Participants
Primary cancer site Prostate	36 participants n=5 Participants	38 participants n=7 Participants	74 participants n=5 Participants
Primary cancer site Others	38 participants n=5 Participants	40 participants n=7 Participants	78 participants n=5 Participants
Number of painful sites 1	115 participants n=5 Participants	116 participants n=7 Participants	231 participants n=5 Participants
Number of painful sites 2	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: ITT

The incidences of radiation-induced pain flare from the time of radiotherapy treatment to ten days after the completion of treatment

Outcome measures

Measure	Dexamethasone n=148 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=150 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Radiation-induced Pain Flare Incidence	39 Participants	53 Participants

SECONDARY outcome

Timeframe: From Day 6 to day 10 after radiotherapy treatment

Population: ITT

Reduction in incidence of radiation-induced pain flare from Day 6 to Day 10 after radiotherapy treatment

Outcome measures

Measure	Dexamethasone n=148 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=150 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Radiation-induced Pain Flare Incidence From Day 6 to Day 10 After Radiotherapy Treatment	32 Participants	35 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Patients with baseline and day 10 Analgesic Use data.

Change in mean analgesic use from baseline to day 10.

Outcome measures

Measure	Dexamethasone n=126 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=129 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Analgesic Use	1.29 mg Standard Deviation 36.0	9.83 mg Standard Deviation 59.4

SECONDARY outcome

Timeframe: From day 0 to 6 weeks

Population: ITT

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:

i. 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

Outcome measures

Measure	Dexamethasone n=148 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=150 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Response to Radiation Treatment at Six Weeks	64 participants	52 participants

SECONDARY outcome

Timeframe: Pain intensity score change from baseline of day 0 to day 10 after radiation

Population: Patients with baseline and day 10 pain evaluation.

Change in pain score over 10 days after radiotherapy, pain score range from 0 (no pain) to 10 (worst pain as can imagine).

Outcome measures

Measure	Dexamethasone n=130 Participants 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=131 Participants 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Change in Pain Intensity Score Over 10 Days After Radiotherapy.	-2.54 units on pain intensity scale Standard Deviation 2.88	-1.99 units on pain intensity scale Standard Deviation 2.59

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 119 other events

Deaths: 119 deaths

Placebo

Serious events: 0 serious events

Other events: 117 other events

Deaths: 117 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexamethasone n=147 participants at risk 2 x 4 mg dexamethasone tablets taken once daily for 5 days Dexamethasone: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days	Placebo n=143 participants at risk 2 placebo tablets taken once daily for 5 days Placebo: 2 placebo tablets taken once daily for 5 days
Gastrointestinal disorders Constipation	32.0% 47/147 • 0 to 6 weeks	25.9% 37/143 • 0 to 6 weeks
Gastrointestinal disorders Diarrhea	4.8% 7/147 • 0 to 6 weeks	7.0% 10/143 • 0 to 6 weeks
Gastrointestinal disorders Dyspepsia	8.2% 12/147 • 0 to 6 weeks	5.6% 8/143 • 0 to 6 weeks
Gastrointestinal disorders Nausea	23.1% 34/147 • 0 to 6 weeks	23.8% 34/143 • 0 to 6 weeks
Gastrointestinal disorders Vomiting	6.1% 9/147 • 0 to 6 weeks	5.6% 8/143 • 0 to 6 weeks
General disorders Edema limbs	3.4% 5/147 • 0 to 6 weeks	5.6% 8/143 • 0 to 6 weeks
General disorders Fatigue	39.5% 58/147 • 0 to 6 weeks	34.3% 49/143 • 0 to 6 weeks
Investigations Cholesterol high	5.4% 8/147 • 0 to 6 weeks	4.2% 6/143 • 0 to 6 weeks
Metabolism and nutrition disorders Anorexia	10.2% 15/147 • 0 to 6 weeks	9.1% 13/143 • 0 to 6 weeks
Musculoskeletal and connective tissue disorders Bone pain	41.5% 61/147 • 0 to 6 weeks	47.6% 68/143 • 0 to 6 weeks
Nervous system disorders Headache	6.1% 9/147 • 0 to 6 weeks	7.7% 11/143 • 0 to 6 weeks
Psychiatric disorders Anxiety	7.5% 11/147 • 0 to 6 weeks	6.3% 9/143 • 0 to 6 weeks
Psychiatric disorders Insomnia	17.7% 26/147 • 0 to 6 weeks	11.9% 17/143 • 0 to 6 weeks
Respiratory, thoracic and mediastinal disorders Cough	6.1% 9/147 • 0 to 6 weeks	4.9% 7/143 • 0 to 6 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	13.6% 20/147 • 0 to 6 weeks	7.0% 10/143 • 0 to 6 weeks

Additional Information

Keyue Ding, Biostatistician

Canadian Cancer Trials Group

Phone: 613-533-6430

Email: kding@ctg.queensu.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place