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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, Italy
RECRUITINGAnemia
Assessment of hemoglobin levels every 4 weeks.
Time frame: 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).
Fatigue
Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.
Time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
Nausea
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.
Time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
Quality of life level: questionnaire
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.
Time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
Tolerability of food supplements
Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.
Time frame: Patients will be followed from date of enrollment for a maximum period of 6 months.
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