American Ginseng (Panax Quinquefolius) for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients Submitted to Adjuvant Chemotherapy After Surgery. A Study of NICSO (Network Italiano Cure di Supporto in Oncologia).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Incidence of cancer related fatigue during chemotherapy.
研究概览
简要总结
Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life.
CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.
详细描述
Cancer related fatigue (CRF) can occur before, during and after anti-cancer treatment. In fact, up to 40% of patients report fatigue at diagnosis, 80%-90% during chemotherapy and radiotherapy, respectively and 20%-50% in the post-treatment phase.
All cancer patients should be screened for the presence of CRF at the first oncological visit and subsequently during and after the anticancer therapies.
If the patient refers CRF, it could be quantified with one of the validate instruments available; the possible determinants could be identified and corrected if possible, to reduce their impact on patients CR.
The most evaluated pharmacological treatments of CRF include psychostimulants (methylphenidate, modafinil, armodafinil) and dexamethasone. Non-pharmacological treatments include physical exercise, psychological therapies and complementary therapies such as agopuncture, yoga, ginseng.
The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in a homogeneous population of breast cancer women submitted to adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind, placebo-controlled
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
- •submitted for the first time to adjuvant chemotherapy with anthracyclines and cyclophosphamide after surgery for breast cancer;
- •not presenting CRF or at least with o al massimo CRF lieve (NRS < 4);
- •18 year old, who have given written informermed consent;
- •who accept to use adequate contraceptive methods, if they are of child-bearing potential.
排除标准
- •previously submitted to chemotherapy;
- •with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit, hypothyroidism, not-controlled diabetes mellitus;
- •submitted to raitherapy during the 15 days before the randomization;
- •presenting moderate-severe fatigue (NRS ≥ 4) at basaline;
- •receivind opioids or corticosteroids (except if admimistered at phisiological doses or to prevent emesis on the chemotherapy day);
- •with with blood cell count < 3000/mm3, platelets < 70000 mm3, hemoglobin < 8 g/dL;
- •unable to understand the procedures of the study or to collaborate with them;
- •pregnant or breastfeeding.
研究组 & 干预措施
Placebo
Placebo: 1 cpr twice a day orally for 3 months
干预措施: Placebo (Other)
American Ginseng
American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months
干预措施: American Ginseng (Dietary Supplement)
结局指标
主要结局
Incidence of cancer related fatigue during chemotherapy.
时间窗: The NRS will be admistered before randomization (baseline assessment) and before each chemotherapy cycle. In addition, the patients must complete the NRS once a day at home, for 90 days.
Incidence will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).
Intensity of cancer related fatigue during chemotherapy.
时间窗: The NRS will be admistered before randomization (baseline assessment) and before each chemotherapy cycle. In addition, the patients must complete the NRS once a day at home, for 90 days.
Intensity will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).moderate-severe fatigue.
次要结局
- Quality of Life (QoL)(These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.)
研究者
Fausto Roila
Medical doctor
Network Italiano Cure di Supporto in Oncologia