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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Eligibility

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

Study details
    Breast Cancer
    Breast Cancer
    Gynecologic Cancer

NCT04474951

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

16 February 2024

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