Clinical trial NCT04474951: Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
Official title: Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Keywords: breast cancer
ovarian cancer
stinging nettle
peppermint
anemia
fatigue
nausea
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anemia
timeFrame: 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).
measure: Fatigue
timeFrame: Patients will be followed from date of enrollment for a maximum period of 6 months.
measure: Nausea
timeFrame: Patients will be followed from date of enrollment for a maximum period of 6 months.
Secondary outcomes:
measure: Quality of life level: questionnaire
timeFrame: Patients will be followed from date of enrollment for a maximum period of 6 months.
measure: Tolerability of food supplements
timeFrame: Patients will be followed from date of enrollment for a maximum period of 6 months.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
name: Claudio Zamagni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31.
citation: Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16.
citation: Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263.