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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anemia | Experimental | 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. |
|
| Fatigue | Experimental | 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. |
|
| Nausea | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stinging Nettle | Dietary Supplement | Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Zamagni, MD | Contact | 051 2144548 | +39 | zamagniclaudio.sper@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Zamagni, MD | Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii | Recruiting | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23390455 | Background | Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31. | |
| 26904610 | Background | Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000740 | Anemia |
| D005221 | Fatigue |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C048862 | stinging nettle lectin |
| C015424 | peppermint oil |
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| Stinging Nettle | Dietary Supplement | Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue. |
|
| Peppermint | Dietary Supplement | Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea. |
|
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. |
| 14716106 | Background | Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |