Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
NCT ID: NCT04474951
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-06-20
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
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.
Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
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.
Peppermint
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
Interventions
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Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
Peppermint
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Scale (KPS) ≥ 90%
* Breast or Gynecological cancer
* Informed consent signed before every procedure study specific, on day 1 of therapy cycle
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Claudio Zamagni MD
MD Medical Oncologist
Principal Investigators
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Claudio Zamagni, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
Locations
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Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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GALENO 1
Identifier Type: -
Identifier Source: org_study_id
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