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Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with breast cancer leading to early discontinuation of this life-saving cancer treatment. No effective pharmacologic therapy has yet been identified for management of these symptoms, as many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis. This effect has not been studied in the setting of Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).
Primary Objectives:
a. To assess whether daily oral Vitamin B12 decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), as measured at baseline, 6 weeks and at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Oral Vitamin B12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B12 | Dietary Supplement | Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline and 90 days (+/- 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Worst Pain at the End of Treatment . | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Zeina Nahleh, MD | Texas Tech University HSC El Paso | Principal Investigator |
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IRB approved recruitment of 50 participants
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Oral Vitamin B12 Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Oral Vitamin B12 Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. | Posted | Mean | Standard Deviation | Percentage change | Baseline and 90 days (+/- 10 days) |
|
90 Days (+/- 10 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Oral Vitamin B12 Vitamin B12: Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dry mouth and nausea | Gastrointestinal disorders | Systematic Assessment |
Five of 41 participants did not complete the study medications and were not analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zeina Nahleh, MD (previoulsy PI at Texas Tech university HSC-EP) | Cleveland Clinic Florida | 9546595840 | nahlehz@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2016 | Jan 4, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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Vitamin B12 is to be taken sublingually on a daily basis for 90 days
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| Baseline and 90 days (+/- 10 days) |
| Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) | 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. | Baseline and 90 days (+/- 10 days) |
| Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA). | Inflammatory markers were measured pre and post treatment. | Baseline and at 90 days (+/- 10 days) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Percentage Change in Worst Pain at the End of Treatment . | 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. | Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level > or=4 using BPI-SF) | Posted | Mean | Standard Deviation | Percentage change | Baseline and 90 days (+/- 10 days) |
|
|
|
|
| Secondary | Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES) | 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. | postemneopausal women with ER + , Stages I-III breast cancer | Posted | Mean | Standard Deviation | Percentage change | Baseline and 90 days (+/- 10 days) |
|
|
|
|
| Secondary | Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA). | Inflammatory markers were measured pre and post treatment. | postmenopasual women receiving AI | Posted | Median | Standard Deviation | Percentage change | Baseline and at 90 days (+/- 10 days) |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 14 |
| 36 |
| blurred vision | Eye disorders | Systematic Assessment | grade 1 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| FWB |
|
| ESS |
|
| 0.056 |
| Other |
| This analysis is comparing PWB before and after treatment. | t-test, 2 sided | <0.0001 | Other |
| This analysis is comparing FWB before and after treatment. | t-test, 2 sided | 0.09 | Other |
| This analysis is comparing ESS before and after treatment. | t-test, 2 sided | <0.0001 | Other |
| Title | Measurements |
|---|
|
| MMA |
|