Breast Cancer, Gynecologic Cancer
Conditions
Keywords
breast cancer, ovarian cancer, stinging nettle, peppermint, anemia, fatigue, nausea
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 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.
Interventions
DIETARY_SUPPLEMENTStinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
DIETARY_SUPPLEMENTPeppermint
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia | 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). | Assessment of hemoglobin levels every 4 weeks. |
| Fatigue | Patients will be followed from date of enrollment for a maximum period of 6 months. | Evaluation of fatigue with questionnaire Brief Fatigue Inventory - BFI, completed by the patients at day 1 of every cycle of chemotherapy. |
| Nausea | Patients will be followed from date of enrollment for a maximum period of 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life level: questionnaire | Patients will be followed from date of enrollment for a maximum period of 6 months. | 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. |
| Tolerability of food supplements | Patients will be followed from date of enrollment for a maximum period of 6 months. | Evaluation of tolerability of food supplements through registration of adverse events at each patient visit. |
Countries
Italy
Contacts
Primary ContactClaudio Zamagni, MD
Outcome results
None listed