Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- fatigue
研究概览
简要总结
Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy. Fatigue is a common symptom in cancer patients including those receiving radiation therapy. We conducted a trial of MVi versus placebo in patients with breast cancer (BC) undergoing radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life. We randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver® (Wyeth-Whitehall laboratory). At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa. Patients answered to the EORTC QLQ C-30 quality of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and at the end of Rxt. We found that both groups experienced significant decreases in general and physical fatigue at the end of the course of placebo compared to the assessment prior to this treatment. We also observed significant improvements in functional and symptoms in the patients on placebo. When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi. We conclude that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt.
详细描述
Multivitamins (MVi) are broadly used by cancer patients to improve overall health and energy. Fatigue is a common symptom in cancer patients including those receiving radiation therapy. We conducted a double blind randomized cross-over trial of MVi versus placebo in patients with breast cancer (BC) undergoing radiation therapy (Rxt) to evaluate if MVi would affect fatigue and quality of life. We randomized forty patients at the beginning of Rxt treatment to either placebo or Centrum Silver® (Wyeth-Whitehall laboratory). At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa. Patients answered to the EORTC QLQ C-30 quality of life (QOL) and Chalder Fatigue Questionnaires at the beginning, the time of switching and at the end of Rxt. When we analyzed the same group of patients throughout the treatment periods, we found that both groups experienced significant decreases in general (p = 0.009; p = 0.001) and physical fatigue scores (p = 0.031; p = 0.029) at the end of the course of placebo compared to the assessment prior to this treatment. We also observed significant improvements in functional (p = 0.026) and symptoms (p = 0.016) score scales of the QOL questionnaire in the patients on placebo. No significant changes were elicited with the use of MVi. When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi (0 vs 25% p = 0.035 for both types of fatigue). We conclude that MVi do not improve radiation related fatigue, and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt. Further studies are needed to confirm our findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •breast cancer who were to receive radiation therapy to the breast after a conservative surgery or after mastectomy
排除标准
- •previous history of radiation therapy,
- •chronic anemia,
- •depression
- •serious psychiatric disorders
结局指标
主要结局
fatigue
次要结局
- quality of life
