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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474951
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Claudio Zamagni MD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Gynecologic Cancer Dietary Supplement: Stinging Nettle Dietary Supplement: Peppermint Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Experimental: Anemia
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.
Dietary Supplement: Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.

Experimental: Fatigue
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.
Dietary Supplement: Stinging Nettle
Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.

Experimental: Nausea
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.
Dietary Supplement: Peppermint
Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.




Primary Outcome Measures :
  1. Anemia [ 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). ]
    Assessment of hemoglobin levels every 4 weeks.

  2. Fatigue [ Time Frame: 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.

  3. Nausea [ Time Frame: 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.


Secondary Outcome Measures :
  1. Quality of life level: questionnaire [ Time Frame: 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.

  2. Tolerability of food supplements [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474951


Contacts
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Contact: Claudio Zamagni, MD 051 2144548 ext +39 zamagniclaudio.sper@aosp.bo.it

Locations
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Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii Recruiting
Bologna, Italy, 40138
Contact: Claudio Zamagni, MD    051 2144548 ext +39    zamagniclaudio.sper@aosp.bo.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Claudio Zamagni, MD Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
Publications:
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Responsible Party: Claudio Zamagni MD, MD Medical Oncologist, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT04474951    
Other Study ID Numbers: GALENO 1
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudio Zamagni MD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
breast cancer
ovarian cancer
stinging nettle
peppermint
anemia
fatigue
nausea
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases