Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies (GALENO 1)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Breast Cancer; Gynecologic Cancer

Treatments: Dietary Supplement: Peppermint; Dietary Supplement: Stinging Nettle

Study type: Interventional

Funder types: Other

Identifiers

NCT04474951

GALENO 1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Anemia

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Stinging Nettle

Dietary Supplement: Stinging Nettle

Fatigue

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Stinging Nettle

Dietary Supplement: Stinging Nettle

Nausea

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Peppermint