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

Primary Purpose

Breast Cancer, Gynecologic Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Stinging Nettle

Peppermint

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, ovarian cancer, stinging nettle, peppermint, anemia, fatigue, nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica AddariiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Anemia

Fatigue

Nausea

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Anemia

Assessment of hemoglobin levels every 4 weeks.

Fatigue

Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.

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.

Secondary Outcome Measures

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.

Tolerability of food supplements

Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.

Full Information

NCT ID

NCT04474951

First Posted

July 14, 2020

Last Updated

July 16, 2020

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT04474951

Brief Title

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

Acronym

GALENO 1

Official Title

Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2019 (Actual)

Primary Completion Date

March 1, 2021 (Anticipated)

Study Completion Date

September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Gynecologic Cancer

Keywords

breast cancer, ovarian cancer, stinging nettle, peppermint, anemia, fatigue, nausea

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anemia

Arm Type

Experimental

Arm Description

Arm Title

Fatigue

Arm Type

Experimental

Arm Description

Arm Title

Nausea

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Stinging Nettle

Intervention Description

Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.

Intervention Type

Dietary Supplement

Intervention Name(s)

Stinging Nettle

Intervention Description

Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.

Intervention Type

Dietary Supplement

Intervention Name(s)

Peppermint

Intervention Description

Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.

Primary Outcome Measure Information:

Title

Anemia

Description

Assessment of hemoglobin levels every 4 weeks.

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).

Title

Fatigue

Description

Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.

Time Frame

Patients will be followed from date of enrollment for a maximum period of 6 months.

Title

Nausea

Description

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.

Time Frame

Patients will be followed from date of enrollment for a maximum period of 6 months.

Secondary Outcome Measure Information:

Title

Quality of life level: questionnaire

Description

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.

Time Frame

Patients will be followed from date of enrollment for a maximum period of 6 months.

Title

Tolerability of food supplements

Description

Evaluation of tolerability of food supplements through registration of adverse events at each patient visit.

Time Frame

Patients will be followed from date of enrollment for a maximum period of 6 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claudio Zamagni, MD

Phone

051 2144548

Ext

+39

zamagniclaudio.sper@aosp.bo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio Zamagni, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudio Zamagni, MD

Phone

051 2144548

Ext

+39

zamagniclaudio.sper@aosp.bo.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23390455

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.

Results Reference

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PubMed Identifier

26904610

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.

Results Reference

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PubMed Identifier

14716106

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.

Results Reference

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

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