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

Breast Cancer Clinical Trial

— GALENO 1  

Official title:

Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474951
• Other study ID #: GALENO 1
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2020
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Claudio Zamagni, MD
• Phone: 051 2144548
• Email: zamagniclaudio.sper[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Gynecologic Cancer
• Signs and Symptoms

Intervention

Dietary Supplement:
• Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
• Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
• Peppermint
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View Citation

Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha × piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Assessment of hemoglobin levels every 4 weeks.	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).
Primary	Fatigue	Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.	Patients will be followed from date of enrollment for a maximum period of 6 months.
Primary	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.	Patients will be followed from date of enrollment for a maximum period of 6 months.
Secondary	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.	Patients will be followed from date of enrollment for a maximum period of 6 months.
Secondary	Tolerability of food supplements	Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.	Patients will be followed from date of enrollment for a maximum period of 6 months.