Vitamin B12 for Aromatase Inhibitors Associated Musculoskeletal Symptoms in Breast Cancer
- Conditions
- HR-positive Breast Cancer
- Registration Number
- NCT04205786
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Subjects must have histologically or cytologically confirmed estrogen receptor (ER)<br> and/or progesterone receptor (PgR) positive invasive carcinoma of the breast (Stage<br> I-III) with no evidence of metastatic disease (M0).<br><br> - Subjects must have completed mastectomy or breast sparing surgery, and must have<br> recovered from all side effects of the surgery. Patients should have recovered from<br> all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the<br> exception of alopecia and peripheral neuropathy. Concurrent bisphosphonate and<br> trastuzumab therapies are allowed<br><br> - Patients must have aromatase inhibitor (AI) associated musculoskeletal symptoms that<br> began or increased after starting AI therapy. New musculoskeletal pain must not be<br> due specifically to fracture or traumatic injury<br><br> - Subjects must currently be taking one of the following aromatase inhibitor (AI)<br> doses for at least 14 days prior to registration and plan to continue for at least<br> an additional 180 days after registration:<br><br> - Anastrozole (Arimidex) 1 mg daily OR<br><br> - Letrozole (Femara) 2.5 mg daily OR<br><br> - Exemestane (Aromasin) 25 mg daily<br><br> - Patients must be post-menopausal, as defined by at least one of the following:<br><br> --= 12 months since their last menstrual period OR<br><br> - Prior bilateral oophorectomy OR<br><br> - Previous hysterectomy with one or both ovaries left in place (or previous<br> hysterectomy in which documentation of bilateral oophorectomy is unavailable)<br> AND (unless = 60 years of age) FSH values consistent with the institutional<br> normal values for the post-menopausal state.<br><br> - Performance status: Patients must have ECOG performance status of 0-2 as assessed by<br> MD or RN<br><br> - Patients must have no known allergy or hypersensitivity to vitamin B12<br><br> - Must have completed the Brief Pain Inventory Short Form (BPI-SF) within 7 days of<br> enrollment (after signing consent, but prior to starting treatment) and have an<br> average pain score of at least 24.<br><br> - Patients must not have any contraindicated concurrent illnesses including:<br><br> - History of alcohol or other substance abuse or dependence within 365 days prior<br> to enrollment.<br><br> - Chronic liver disease.<br><br> - End stage renal disease.<br><br> - Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or<br> pregabalin must have been taking a stable dose for at least 30 days prior to<br> registration.<br><br> - Patients must be able to complete study questionnaires in English.<br><br> - Patients who are currently taking vitamin B12 or a multivitamin containing vitamin<br> B12 will be able to participate in the study after having stopped taking the vitamin<br> B12 or the multivitamin containing the B12 for two weeks before day 1 of treatment.<br><br> - Patients must be willing to submit blood samples for laboratory testing [to test for<br> Serum Vitamin B12, CRP, homocysteine level, complete blood count (CBC), potassium,<br> and MMA]. Baseline samples must be obtained prior to beginning protocol treatment.<br><br> - All patients or their legally authorized representative must be informed of the<br> investigational nature of this study and must sign and give written informed consent<br> in accordance with institutional and federal guidelines.<br><br> - Subjects must have the ability to understand and the willingness to sign a written<br> informed consent document.<br><br>Exclusion Criteria:<br><br> - Subjects receiving any other investigational agents.<br><br> - History of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to vitamin B12 or other agents used in this study.<br><br> - Subjects with uncontrolled intercurrent illness including, but not limited to<br> chronic liver disease, end stage renal disease, ongoing or active infection,<br> symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,<br> or psychiatric illness/social situations that would limit compliance with study<br> requirements
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in average joint pain according to the Brief Pain Inventory - Short Form (BPI- SF)
- Secondary Outcome Measures
Name Time Method Change in worst joint pain according to the BPI-SF;Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)