Trial Outcomes & Findings for Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome (NCT NCT03665077)

NCT ID: NCT03665077

Last Updated: 2023-08-24

Results Overview

Change Oxylipin levels at Baseline, Three and Six Months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Baseline, Three months, and Six months
• Results posted on: 2023-08-24

Participant Flow

Postmenopausal women with early-stage breast cancer prior to starting adjuvant endocrine therapy with aromatase inhibitors

This is a single arm observational study

Participant milestones

Measure	Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Overall Study STARTED	28
Overall Study 3 Months Blood Draw	22
Overall Study 6 Months Blood Draw	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	2

Baseline Characteristics

Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

Baseline characteristics by cohort

Measure	Participants n=28 Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	66.0 Years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants
Stage of Cancer Stage 0	8 Participants n=5 Participants
Stage of Cancer Stage 1	17 Participants n=5 Participants
Stage of Cancer Stage 2	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Three months, and Six months

Change Oxylipin levels at Baseline, Three and Six Months

Outcome measures

Measure	Participants n=24 Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Oxylipin Levels Baseline	10.2 pg/mL Standard Deviation 5.9
Oxylipin Levels 3 Months	12.1 pg/mL Standard Deviation 7.8
Oxylipin Levels 6 Months	12.3 pg/mL Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline

Population: Patients with breast cancer on adjuvant aromatase inhibitor.

Tendon stiffness at baseline

Outcome measures

Measure	Participants n=16 Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Tendon Stiffness Abductor pollicis longus (Baseline)	5.59 m/s Standard Deviation 2.46
Tendon Stiffness Median nerve (Baseline)	5.56 m/s Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, Six months

Population: Patients with early stage breast cancer on adjuvant aromatase inhibitor.

Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20.

Outcome measures

Measure	Participants n=24 Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Initial blood draw: At baseline, patients will undergo a blood draw. Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. Blood draw at three months: Blood drawn at three months to evaluate oxylipins. Blood draw at six months: Blood drawn at six months to evaluate oxylipins. SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.
Pain Levels Baseline	8.0 score on a scale Standard Deviation 14.6
Pain Levels 6 Months	12.3 score on a scale Standard Deviation 17.6

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pavani Chalasani

George Washington Cancer Center

Phone: (202)-741-2277

Email: pavani.chalasani@email.gwu.edu

Results disclosure agreements

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