Status:
UNKNOWN
Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Breast Cancer
Gynecologic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04474951
Start Date
June 20 2019
End Date
September 1 2021
Last Update
July 17 2020
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, Italy, 40138