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.

Breast Cancer

Gynecologic Cancer

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.

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

Peppermint

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

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

Food Supplements to Control Signs and Symptoms Induced by Cancer Therapies

Assessment of hemoglobin levels every 4 weeks.

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

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.

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.

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

Claudio Zamagni MD

MD Medical Oncologist

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

For the patients of the test-group Urtica comp gel is applied three times per day locally on the skin as soon as the patient senses "itching, tingling" and/or reddening. Otherwise the skincare is exactly as the control group in line with the departments general guidelines.
In case of marked worsening, e.g. epitheliolysis, the patient may receive "Flammazine and Ialugen plus" as rescue-care.
Rescue care: according to the departments therapeutic guidelines patients will receive "Flammazine and/or Ialugen plus" as clinically indicated at the discretion of the treating physician (usually in cases of marked worsening of the skin condition like e.g. epitheliolysis).

Control group receiving the institutional standard skin care "Excipial-Hydrolotion" - all other therapeutic interventions, assessments and rescue-care will be the same in both groups.

Radiation Dermatitis

Urtica comp. gel is a Swissmedic registered medication. The scope of application of Urtica comp. is an imbalanced, affected process of skin-regeneration, in particular when stemming from an overdose of heat or light.
It is applied in first and second-degree burn and scalding, sunburn, allergic and hyperergic (excessive) skin conditions (dermatoses), insect bites, abrasions and ulcers.

Urtica comp. gel

The institutional standard skin care "Excipial-Hydrolotion" is available to all patients

institutional standard skin care "Excipial-Hydrolotion"

Universitätsklinik für Radio-Onkologie

Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)

Comparison between both arms measuring the use of Flammazine or Ialugen plus (rescue-care)

Comparison between both arms. The FACIT-TS-G (Functional Assessment of Chronic Illness Therapy treatment satisfaction - General) assesses the patients treatment satisfaction at the end of therapy (EOT after 6 weeks of Radiation therapy).
The questionnaire consists of 8 questions, 3 of which are answered on a scale ranging from 0 (much worse) to 4 (much better), 3 questions ranging from 0 (not al all) to 3 (totally) and two questions which can be answered with 0 (no), 1(maybe) and 2 (yes). Thus on all scales a higher value represents a better outcome. The total score range is 0 (not satisfied at all) to 25 (highly satisfied).

with the Skin Condition VAS the patient self-assesses the skin condition in the radiation area.
The questionnaire consists of 5 subscales: pain, itching, burning, irritation, visual appearance. Each scale ranges from 0 (not apparent) to 100 (worst possible expression). For the total score all values are summed up and divided by 5 (number of scales) resulting in a total score ranging from 0 (best possible outcome = no skin affection due to radiation) to 100 (worst possible outcome).

urtica dioica/καρκίνος

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

Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

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