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

Not Applicable

• Conditions: Gynecologic Cancer; Breast Cancer
• Interventions: Dietary Supplement: Peppermint; Dietary Supplement: Stinging Nettle

• Registration Number: NCT04474951
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-20
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nausea	Peppermint	20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.
Fatigue	Stinging Nettle	Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.
Anemia	Stinging Nettle	Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii; 🇮🇹 Bologna, Italy