Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies

Study Overview
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Brief Summary
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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.

Official Title
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Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies

Conditions
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Breast Cancer, Gynecologic Cancer

Intervention / Treatment
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* Dietary Supplement: Stinging Nettle
* Dietary Supplement: Stinging Nettle
* Dietary Supplement: Peppermint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anemia<br>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: Stinging Nettle<br>* Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.<br>|
| Experimental: Fatigue<br>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: Stinging Nettle<br>* Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.<br>|
| Experimental: Nausea<br>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: Peppermint<br>* Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia | Assessment of hemoglobin levels every 4 weeks. | 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). | 
| Fatigue | Evaluation of fatigue with questionnaire Brief Fatigue Inventory - BFI, completed by the patients at day 1 of every cycle of chemotherapy. | Patients will be followed from date of enrollment for a maximum period of 6 months. | 
| Nausea | 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. | Patients will be followed from date of enrollment for a maximum period of 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life level: questionnaire | Evaluation of quality of life with questionnaire EQ-5D, completed at day 1 of every cycle of chemotherapy by patients enrolled in the three arms. | Patients will be followed from date of enrollment for a maximum period of 6 months. | 
| Tolerability of food supplements | Evaluation of tolerability of food supplements through registration of adverse events at each patient visit. | Patients will be followed from date of enrollment for a maximum period of 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, ovarian cancer, stinging nettle, peppermint, anemia, fatigue, nausea