Trial Outcomes & Findings for Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms (NCT NCT03069313)
NCT ID: NCT03069313
Last Updated: 2018-02-01
Results Overview
The Brief Pain Inventory - Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine" We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours.
COMPLETED
NA
41 participants
Baseline and 90 days (+/- 10 days)
2018-02-01
Participant Flow
we needed at least a total of 30 patients to achieve more than 85% power to detect the differences in BPI-SF pain scores relative to baseline using a two tailed paired t-test with 5% level of significance. After accounting for 15% dropouts, we estimated to include at least 35 patients in the study.
IRB approved recruitment of 50 participants
Participant milestones
| Measure |
Arm I
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Arm I
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
Baseline Characteristics
Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms
Baseline characteristics by cohort
| Measure |
Arm I
n=41 Participants
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 90 days (+/- 10 days)Population: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study.
The Brief Pain Inventory - Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine" We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours.
Outcome measures
| Measure |
Arm I
n=36 Participants
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF).
|
-33.8 Percentage change
Standard Deviation 34.1
|
SECONDARY outcome
Timeframe: Baseline and 90 days (+/- 10 days)Population: Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level \> or=4 using BPI-SF)
Analysis of the data collected at baseline and at the end of treatment in the BPI-SF questionnaire. The Brief Pain Inventory - Short Form (BPI- SF) worst pain score used. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Participants were asked to rate worst pain an average pain within the last 24 hours.
Outcome measures
| Measure |
Arm I
n=36 Participants
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Percentage Change in Worst Pain at the End of Treatment .
|
-23.03 Percentage change
Standard Deviation 43.1
|
SECONDARY outcome
Timeframe: Baseline and 90 days (+/- 10 days)Population: postemneopausal women with ER + , Stages I-III breast cancer
All of the items in this questionnaire have a 5 scale rating, from not at all (0) to very much (4). Outcomes were measured pre and post treatment. Version 4 of the FACT-ES contains 3 subscales with seven questions: Physical Well-Being (PWB) (score range 0-28), Functional Well-Being (FWB) (score range 0-28), and Social and Well-Being (SWB) (score range 0-28); Emotional Well-Being (EWB) (score range 0-24) with six questions, and the Endocrine Symptom Subscale (ESS) (score range 0-76) containing 19 questions. For all subscale a higher score represents better quality of life.
Outcome measures
| Measure |
Arm I
n=36 Participants
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
SWB
|
10.02 Percentage change
Standard Deviation 27.7
|
|
Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
EWB
|
10.8 Percentage change
Standard Deviation 38.6
|
|
Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
PWB
|
46.3 Percentage change
Standard Deviation 62.5
|
|
Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
FWB
|
18 Percentage change
Standard Deviation 45
|
|
Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)
ESS
|
15.6 Percentage change
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline and at 90 days (+/- 10 days)Population: postmenopasual women receiving AI
Inflammatory markers were measured pre and post treatment.
Outcome measures
| Measure |
Arm I
n=36 Participants
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
B12
|
209.8 Percentage change
Standard Deviation 191.3
|
|
Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
CRP
|
64.2 Percentage change
Standard Deviation 298.5
|
|
Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
HCys
|
-24.6 Percentage change
Standard Deviation 19.75
|
|
Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).
MMA
|
-7.1 Percentage change
Standard Deviation 81.65
|
Adverse Events
Arm I
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=36 participants at risk
Oral Vitamin B12
Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
|
|---|---|
|
Gastrointestinal disorders
dry mouth and nausea
|
38.9%
14/36 • Number of events 19 • 90 Days (+/- 10 days)
|
|
Eye disorders
blurred vision
|
2.8%
1/36 • Number of events 1 • 90 Days (+/- 10 days)
|
Additional Information
Zeina Nahleh, MD (previoulsy PI at Texas Tech university HSC-EP)
Cleveland Clinic Florida
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place