Trial Outcomes & Findings for Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim (NCT NCT01752907)

Last Updated: 2022-11-29

Results Overview

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

304 participants

Primary outcome timeframe

Days 1 to 5 during cycle 1.

Results posted on

2022-11-29

Participant Flow

This study was conducted at 48 centers in the United States. Patients with stage I to III breast cancer planning to receive standard neoadjuvant or adjuvant chemotherapy regimens with pegfilgrastim support for at least 4 cycles were included. The first participant enrolled on 17 January 2013 and the last participant enrolled on 04 September 2014.

Participants were randomized in a 1:1 ratio to receive 1 of 2 educational DVDs: general chemotherapy side effects education DVD (GE-DVD) or bone pain education DVD (BP-DVD). Participants remained on study for the first 4 chemotherapy cycles. End of study occurred 30 days after administration of pegfilgrastim in the fourth cycle of chemotherapy.

Participant milestones

Participant milestones
Measure	General Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Overall Study STARTED	151	153
Overall Study Received Pegfilgrastim	149	151
Overall Study COMPLETED	139	133
Overall Study NOT COMPLETED	12	20

Reasons for withdrawal

Reasons for withdrawal
Measure	General Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Overall Study Withdrawal by Subject	4	10
Overall Study Lost to Follow-up	2	1
Overall Study Decision by Sponsor	6	9

Baseline Characteristics

Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Total n=300 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	54.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	54.0 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	149 Participants n=5 Participants	151 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black (or African American)	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
Race/Ethnicity, Customized White	128 participants n=5 Participants	124 participants n=7 Participants	252 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 to 5 during cycle 1.

Population: Full analysis set with imputation

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Maximum Patient-reported Bone Pain in Cycle 1	3.2 units on a scale Standard Error 0.2	3.5 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Days 1-5 for each treatment cycle

Population: Full analysis set with imputation

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 2 (n=145, 144)	2.5 units on a scale Standard Deviation 0.2	2.7 units on a scale Standard Deviation 0.3
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 4 (n=141, 133)	2.4 units on a scale Standard Deviation 0.2	2.5 units on a scale Standard Deviation 0.3
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 3 (n=142, 139)	2.7 units on a scale Standard Deviation 0.2	2.6 units on a scale Standard Deviation 0.2
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles All Cycles (n-149, 151)	4.1 units on a scale Standard Deviation 0.3	4.6 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Days 1-5 for 4 treatment cycles

Population: Full analysis set with imputation

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Mean Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 1 (n=149, 151)	1.6 units on a scale Standard Error 0.2	1.8 units on a scale Standard Error 0.2
Mean Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 2 (n=145, 144)	1.3 units on a scale Standard Error 0.1	1.5 units on a scale Standard Error 0.2
Mean Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 3 (n=142, 139)	1.4 units on a scale Standard Error 0.2	1.4 units on a scale Standard Error 0.2
Mean Patient-reported Bone Pain by Cycle and Across All Cycles Cycle 4 (n=141, 133)	1.3 units on a scale Standard Error 0.1	1.5 units on a scale Standard Error 0.2
Mean Patient-reported Bone Pain by Cycle and Across All Cycles All cycles (n=149, 151)	1.5 units on a scale Standard Error 0.1	1.6 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Days 1-5 for 4 treatment cycles

Population: Full analysis set with imputation

Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles Cycle 1 (n=149, 151)	6.7 units on a scale * days Standard Error 0.6	7.6 units on a scale * days Standard Error 0.7
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles Cycle 2 (n=145, 144)	5.4 units on a scale * days Standard Error 0.6	6.3 units on a scale * days Standard Error 0.7
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles Cycle 4 (n=141, 133)	5.6 units on a scale * days Standard Error 0.6	6.2 units on a scale * days Standard Error 0.7
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles All Cycles (n=149, 151)	6.3 units on a scale * days Standard Error 0.6	6.6 units on a scale * days Standard Error 0.6
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles Cycle 3 (n=142, 139)	6.2 units on a scale * days Standard Error 0.6	6.1 units on a scale * days Standard Error 0.7

SECONDARY outcome

Timeframe: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks

Population: Full analysis set

Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting Cycle 3 (n=142, 139)	37.3 percentage of participants	35.3 percentage of participants
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting Cycle 4 (n= 141, 133)	38.3 percentage of participants	37.6 percentage of participants
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting All cycles (n=149, 151)	58.4 percentage of participants	56.3 percentage of participants
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting Cycle 1 (n=149, 151)	43.0 percentage of participants	40.4 percentage of participants
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting Cycle 2 (n=145, 144)	37.2 percentage of participants	35.4 percentage of participants

SECONDARY outcome

Timeframe: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.

Population: Full analysis set

Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting Cycle 1 (n=149, 151)	2.0 percentage of participants	5.3 percentage of participants
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting Cycle 2 (n=145, 144)	0.0 percentage of participants	2.1 percentage of participants
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting Cycle 4 (n=141, 133)	2.8 percentage of participants	3.8 percentage of participants
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting All cycles (n=149, 151)	4.7 percentage of participants	6.6 percentage of participants
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting Cycle 3 (n=142, 139)	0.0 percentage of participants	2.2 percentage of participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.

Population: Full analysis set

Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.

Outcome measures

Outcome measures
Measure	General Education DVD n=149 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.	Bone Pain Education DVD n=151 Participants Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles Cycle 1 (n=149, 151)	74.5 percentage of participants	73.5 percentage of participants
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles Cycle 2 (n=145, 144)	69.0 percentage of participants	65.3 percentage of participants
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles Cycle 3 (n=142, 139)	65.5 percentage of participants	66.2 percentage of participants
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles Cycle 4 (n=141, 143)	68.8 percentage of participants	69.2 percentage of participants
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles All cycles (n=149, 151)	85.2 percentage of participants	80.1 percentage of participants

Adverse Events

General Chemotherapy Education DVD

Serious events: 16 serious events

Other events: 138 other events

Deaths: 0 deaths

Bone Pain Education DVD

Serious events: 20 serious events

Other events: 144 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER