A Single Arm Phase II Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors (AI) Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- 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).
研究概览
简要总结
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).
详细描述
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:
- To investigate whether daily vitamin B12 improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES);
- To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent and Pain level > 4 in the BPI scale,
- •Stage I-III
排除标准
- •BPI Score <4
- •Zubrod score >2
研究组 & 干预措施
Arm I
Oral Vitamin B12
干预措施: Vitamin B12 (Dietary Supplement)
结局指标
主要结局
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).
时间窗: Baseline and 90 days (+/- 10 days)
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.
次要结局
- Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)(Baseline and 90 days (+/- 10 days))
- Percentage Change in Worst Pain at the End of Treatment .(Baseline and 90 days (+/- 10 days))
- Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).(Baseline and at 90 days (+/- 10 days))
研究者
Zeina Nahleh
Professor
Texas Tech University Health Sciences Center, El Paso