Study of the Impact of a Nutraceutical on Pain in Women With Musculoskeletal Symptoms Associated With Hormonal Therapy With Aromatase Inhibitors, in ER and/or PgR Positive Breast Cancer, After Antitumor Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
研究概览
简要总结
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy in ER- and/or PR-positive breast cancer.
详细描述
ER- and/or PR-positive breast cancer is treated with hormone therapy. There is a relationship between the administration of hormone therapy and the presence and/or exacerbation of joint pain in patients with breast cancer.
The administration of food supplement may result in an improvement of pain, as measured by the mBPI-sf questionnaire, in patients undergoing treatment with Aromatase Inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).
- •Surgical treatment completed and any surgery-related complications resolved.
- •Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).
- •Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.
- •"Average pain" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.
- •ECOG performance status of 0-
- •Patients able to provide informed consent.
排除标准
- •Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic/inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.
- •Chemotherapy and/or radiotherapy completed within 28 days prior to enrollment or baseline visit, and/or unresolved Grade ≥2 side effects related to chemotherapy and/or radiotherapy, except for alopecia and peripheral neuropathy.
- •Known allergy or hypersensitivity to Tenflex®.
- •Pregnant or breastfeeding patients.
研究组 & 干预措施
Experimental
There is only one arm in the study. All patients will be treated with the experimental food supplement.
干预措施: Food supplement (Dietary Supplement)
结局指标
主要结局
Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
时间窗: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
To evaluate the change in average pain intensity as measured by the modified Brief Pain Inventory-Short Form (mBPI-sf) from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains 11 items and these score 0 to 10 being higher the worse pain.
次要结局
- Percentage of patients with ≥30% reduction in average pain.(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)
- Changes in other mBPI-sf domains.(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)
- Change in quality of life Short Form 12-Item Health Survey (SF-12).(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)
- Change in quality of life 'BREAST-Q Reconstruction/Reduction/Augmentation Module'.(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)
- Percentage of patients with ≥30% reduction in average pain.(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)
- Changes in other mBPI-sf domains.(Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.)