Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
Keywords
Abstract
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/13/2020 |
| Estimated Enrollment Submitted: | 07/15/2020 |
| First Posted: | 07/16/2020 |
| Last Update Submitted: | 07/15/2020 |
| Last Update Posted: | 07/16/2020 |
| Actual Study Start Date: | 06/19/2019 |
| Estimated Primary Completion Date: | 02/28/2021 |
| Estimated Study Completion Date: | 08/31/2021 |
Condition or disease
Intervention/treatment
Dietary Supplement: Anemia
Dietary Supplement: Fatigue
Dietary Supplement: Nausea
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | Dietary Supplement: Anemia Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia. |
| Experimental: 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. | Dietary Supplement: Fatigue Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue. |
| Experimental: 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. | Dietary Supplement: Nausea Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Anemia [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).]
2. Fatigue [Patients will be followed from date of enrollment for a maximum period of 6 months.]
3. Nausea [Patients will be followed from date of enrollment for a maximum period of 6 months.]
Secondary Outcome Measures
1. Quality of life level: questionnaire [Patients will be followed from date of enrollment for a maximum period of 6 months.]
2. Tolerability of food supplements [Patients will be followed from date of enrollment for a maximum period of 6 months.]
