Does Radiation Therapy Adversely Affect the Immune System, and Can Acupuncture Ameliorate the Effect? A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in immune biomarker levels
研究概览
简要总结
Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without chemotherapy, affects the immune system, and to determine if acupuncture can modify these effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or genitourinary (GU) cancers.
Clinical or Research Questions:
- Does RT reduce immune biomarkers in treated subjects?
- Which biomarkers are most affected by treatment?
- Is acupuncture a feasible option to help ameliorate any biomarker effects?
- Does RT affect subject symptoms?
- Is acupuncture a feasible option to help ameliorate any symptom effects?
详细描述
Research indicates that patients undergoing curative RT for various cancers experience adverse immune effects, as indicated by reduced biomarker levels and activity. RT has been observed to cause a striking reduction in total lymphocyte count, affecting mainly the T-cells. Furthermore, the reduction in the lymphocyte count after RT has been correlated with poorer outcome for bladder cancer, head and neck cancer, uterine cancer, and brain metastases.
Research into the use of complementary and alternative medicine (CAM) has been conducted to determine the utility of these treatments in addressing the unmet needs of many patients with cancer. There is preliminary evidence that acupuncture, in particular, is successful at improving many cancer and treatment associated effects. Earlier studies have indicated that acupuncture can play a role in regulating immune system response to various morbidities, including chemotherapy induced immunosuppression. However, little research has examined is potential for radiation therapy patients
This pilot study aims to assess a wide range of general immune biomarkers to identify biomarkers most affected by RT. Through use of a symptom assessment survey, changes in self reported symptoms will also be recorded. The feasibility of acupuncture as a strategy to ameliorate any adverse immune or symptom effects will also be examined. This information could be very useful in planning future studies on RT and the immune system, or the potential immune benefits of acupuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will receive ≥ 4 weeks of curative intent long course RT for a GI or GU malignancy
- •patients may or may not have received / be receiving adjuvant chemotherapy
- •anticipated survival of at least 12 months
- •able to visit the BCCA VIC for treatment and 2 follow up visits
排除标准
- •scheduled to receive RT for a period of less than 4 weeks
- •expected survival period is less than 12 months
- •are on anticoagulants
研究组 & 干预措施
Standard treatment
Patients receiving standard radiation therapy for gastrointestinal or urogenital cancers.
All subjects will be asked to give 20 mL of blood and complete the Edmonton Symptom Assessment Form (ESAS) on 3 occasions:
- before radiation
- at 1st follow up 4-10 weeks after radiation completion
- at second follow up 6 months after 1st follow up
Acupuncture
Patients receiving standard radiation therapy for gastrointestinal or urogenital cancers with concurrent acupuncture once a week for 4 weeks.
All subjects will be asked to give 20 mL of blood and complete the Edmonton Symptom Assessment Form (ESAS) on 3 occasions:
- before radiation
- at 1st follow up 4-10 weeks after radiation completion
- at second follow up 6 months after 1st follow up
干预措施: Medical Acupuncture (Procedure)
结局指标
主要结局
Changes in immune biomarker levels
时间窗: As measured using 3 blood samples collected: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up
Change in 21 immune cell types after RT (levels before RT - levels 1st follow up) will be analyzed for controls (to determine if RT reduces immune markers) and experimentals (to determine if acupuncture ameliorates RT effects). Results will be analyzed to determine which biomarkers experienced the largest changes for controls (to identify biomarkers affected by RT) and experimentals (to determine which biomarkers are particularly improved by acupuncture). Change in cell levels during follow up (levels 1st follow up - levels 2nd follow up), will be analyzed to determine duration of changes.
次要结局
- Changes in Symptom Scores(As measured using the Edmonton Symptom Assessment Scores (ESAS) completed: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up)