Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nausea
研究概览
简要总结
The main purpose of this study is to evaluate the impact of food supplements (herbal remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea. Secondary aims of the trial are to evaluate the impact of these supplements on the quality of life and to evaluate their tolerability profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥ 18 years
- •Karnofsky Performance Scale (KPS) ≥ 90%
- •Breast or Gynecological cancer
- •Informed consent signed before every procedure study specific, on day 1 of therapy cycle
- •Inclusion Criteria Arm 1: presence of grade 1 anemia as per CTCAE 4.0 criteria; patients on treatment with anti-CDK 4/6 or PARP Inhibitors or in adjuvant therapy with hormone therapy
- •Inclusion Criteria Arm 2: presence of fatigue of any grade; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane
- •Inclusion Criteria Arm 3: presence of nausea of any grade, without vomiting; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane
排除标准
- •Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment
- •Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical hypothyroidism not compensated by replacement therapy; Persistent insomnia
- •Arm 3: patients with evidence of anxiety or anxious-depressive syndrome
研究组 & 干预措施
Anemia
Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.
干预措施: Stinging Nettle (Dietary Supplement)
Fatigue
Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.
干预措施: Stinging Nettle (Dietary Supplement)
Nausea
20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.
干预措施: Peppermint (Dietary Supplement)
结局指标
主要结局
Nausea
时间窗: Patients will be followed from date of enrollment for a maximum period of 6 months.
Evaluation of nausea with questionnaire "Multinational Association of Supportive Care in Cancer" - MAT, completed by the patients at day 2 and day 5 of every cycle of chemotherapy.
Fatigue
时间窗: Patients will be followed from date of enrollment for a maximum period of 6 months.
Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.
Anemia
时间窗: Patients will be followed from date of enrollment for a maximum period of 6 months. Hemoglobin levels monitoring performed for a maximum period of 6 months or until the worsening of anemia (Hb<10 g/dL).
Assessment of hemoglobin levels every 4 weeks.
次要结局
- Quality of life level: questionnaire(Patients will be followed from date of enrollment for a maximum period of 6 months.)
- Tolerability of food supplements(Patients will be followed from date of enrollment for a maximum period of 6 months.)
研究者
Claudio Zamagni MD
MD Medical Oncologist
IRCCS Azienda Ospedaliero-Universitaria di Bologna