Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Adherence to moxa regimen assessed by Daily Moxa Diary
研究概览
简要总结
This study investigates whether it is feasible to teach cancer patients undergoing chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects. Moxibustion is a therapy used in traditional Chinese medicine that uses heat.
详细描述
Chemotherapy drugs are used to treat cancer cells. However, they can also affect bone marrow and reduce the ability to make certain types of blood cells. Low white blood cell counts can leave patients vulnerable to infection. Low red blood cell counts can lead to anaemia and feelings of fatigue and weakness. Low platelet counts can lead to bruising and bleeding. Blood counts are therefore monitored. If they fall too low, the dose of chemotherapy may be reduced or the time between doses extended. This may affect survival as well as quality of life.
Research studies in China and the West suggest that moxibustion applied by a practitioner can improve blood counts and immunity, and reduce side effects of chemotherapy. Moxibustion (also called moxa) is a form of traditional Chinese medicine that uses heat to stimulate acupuncture points. This heat comes from a smouldering herb called mugwort, that is rolled into a cigar shape to gently warm the point. Many patients regard this as a pleasant, relaxing experience.
The researchers will teach patients to self-administer moxa to an acupuncture point just below the knee. This is a feasibility study to see if patients are willing and able to self-administer moxa daily throughout chemotherapy. Patients will keep a moxa diary to record their activity. The researchers will also use a questionnaire to assess whether patients see themselves as active managers of their health. This may help the researchers to screen suitable patients in future studies.
The researchers will also monitor blood counts, any delays or dose reductions to the chemotherapy, and any chemotherapy side effects. Participants will complete quality of life questionnaires at intervals during and after their chemotherapy.
If results are favourable, they will be used to design a randomised controlled trial comparing daily moxibustion with a "no treatment" control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with breast, gynaecologic, or colorectal cancer who are prescribed radical or adjuvant chemotherapy in the early disease setting, or first or second line chemotherapy is in the metastatic setting
- •about to commence a course of chemotherapy for which granulocyte-colony stimulating factor (G-CSF) is not routinely indicated
- •with a life expectancy of more than six months
- •with blood cell counts within the normal range
- •with calculated creatinine levels of ≥ 50ml/min
- •English speaking
- •able to understand instructions for self-administration of moxibustion and carry out the procedure
- •able to give informed consent
排除标准
- •having a haematological cancer diagnosis
- •prescribed a chemotherapy regimen for which G-CSF is indicated
- •having third or fourth line chemotherapy
- •having metastatic bone cancer
- •who have concomitant severe medical problems preventing participation
- •with cognitive impairment that would impact participant's ability to safely administer self-moxibustion
- •having renal dysfunction
- •with lymphedema in the lower body.
结局指标
主要结局
Adherence to moxa regimen assessed by Daily Moxa Diary
时间窗: 21 days after last chemotherapy cycle
The primary aim of this study is to assess the feasibility of teaching cancer patients undergoing chemotherapy in the National Health Service (NHS) to self-administer daily indirect moxibustion to St 36 Zusanli, according to a protocol that begins ideally 7 to 10 days prior to the first chemotherapy cycle and continues until 21 days after the final chemotherapy cycle. Participants will complete a Daily Moxa Diary to record their adherence to the daily protocol. They will be asked also to log any days they miss, and give reasons why.
次要结局
- Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets(Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106))
- Variation to planned chemotherapy schedule(Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106))
- Chemotherapy related toxicities(Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106))
- Health related quality of life (HRQOL)(At Baseline, cycles 2, 3, and 6 (or final cycle), and one month after final cycle: typically Days 15, 29, 71, 127 for colorectal; Days 22, 43, 106, 134 for breast and gynaecological cancers)
- Patient self-management(At Baseline, cycle 3, and one month after final cycle: typically Days 29 and 127 for colorectal; Days 43 and 134 for breast and gynaecological cancers)
- Safety assessed by all incidents including allergies, burns, and other accidents(Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen)
- Incidents of additional interventions administered as prophylaxis or therapy to maintain or improve blood counts(Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen)
研究者
Beverley de Valois PhD LicAc FBAcC
Research Acupuncturist
East and North Hertfordshire NHS Trust