American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

Study Overview
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Brief Summary
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Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life. CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Detailed Description
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Cancer related fatigue (CRF) can occur before, during and after anti-cancer treatment. In fact, up to 40% of patients report fatigue at diagnosis, 80%-90% during chemotherapy and radiotherapy, respectively and 20%-50% in the post-treatment phase. All cancer patients should be screened for the presence of CRF at the first oncological visit and subsequently during and after the anticancer therapies. If the patient refers CRF, it could be quantified with one of the validate instruments available; the possible determinants could be identified and corrected if possible, to reduce their impact on patients CR. The most evaluated pharmacological treatments of CRF include psychostimulants (methylphenidate, modafinil, armodafinil) and dexamethasone. Non-pharmacological treatments include physical exercise, psychological therapies and complementary therapies such as agopuncture, yoga, ginseng. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in a homogeneous population of breast cancer women submitted to adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Official Title
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American Ginseng (Panax Quinquefolius) for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients Submitted to Adjuvant Chemotherapy After Surgery. A Study of NICSO (Network Italiano Cure di Supporto in Oncologia).

Conditions
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Cancer Related Fatigue, Breast Cancer Female

Intervention / Treatment
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* Dietary Supplement: American Ginseng
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: submitted for the first time to adjuvant chemotherapy with anthracyclines and cyclophosphamide after surgery for breast cancer; not presenting CRF or at least with o al massimo CRF lieve (NRS < 4); 18 year old, who have given written informermed consent; who accept to use adequate contraceptive methods, if they are of child-bearing potential. Exclusion Criteria: previously submitted to chemotherapy; with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit, hypothyroidism, not-controlled diabetes mellitus; submitted to raitherapy during the 15 days before the randomization; presenting moderate-severe fatigue (NRS ≥ 4) at basaline; receivind opioids or corticosteroids (except if admimistered at phisiological doses or to prevent emesis on the chemotherapy day); with with blood cell count < 3000/mm3, platelets < 70000 mm3, hemoglobin < 8 g/dL; unable to understand the procedures of the study or to collaborate with them; pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: American Ginseng<br>American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months | Dietary Supplement: American Ginseng<br>* cpr<br>|
| Placebo Comparator: Placebo<br>Placebo: 1 cpr twice a day orally for 3 months | Other: Placebo<br>* cpr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cancer related fatigue during chemotherapy. | Incidence will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue). | The NRS will be admistered before randomization (baseline assessment) and before each chemotherapy cycle. In addition, the patients must complete the NRS once a day at home, for 90 days. | 
| Intensity of cancer related fatigue during chemotherapy. | Intensity will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).moderate-severe fatigue. | The NRS will be admistered before randomization (baseline assessment) and before each chemotherapy cycle. In addition, the patients must complete the NRS once a day at home, for 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) | QoL will be evaluated through validated instruments: the Brief Fatigue Inventory (BFI) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30), Italian version. | These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Ginseng, Cancer related fatigue, Breast Cancer Female