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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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Updated on 16 February 2024
See if I qualify
cancer
carboplatin
taxane
hormone therapy
cyclophosphamide
endocrine therapy
cancer treatment
immunomodulators
epirubicin
fatigue
adjuvant therapy
cancer therapy
parp inhibitor
immunostimulant
vomit
stinging nettle
inhibitors, parp
adjuvant

Summary

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.

Details
Condition Breast Cancer, Breast Cancer, Gynecologic Cancer
Age 18years - 100years
Treatment Stinging Nettle, Stinging Nettle, Peppermint
Clinical Study IdentifierNCT04474951
SponsorAzienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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cancer
carboplatin
taxane
hormone therapy
cyclophosphamide
endocrine therapy
cancer treatment
immunomodulators
epirubicin
fatigue
adjuvant therapy
cancer therapy
parp inhibitor
immunostimulant
vomit
stinging nettle
inhibitors, parp
adjuvant

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