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

Network Italiano Cure di Supporto in Oncologia

Status

Unknown

Conditions

Cancer Related Fatigue

Breast Cancer Female

Treatments

Dietary Supplement: American Ginseng

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03730298

NICSO-GINSENG

Details and patient eligibility

About

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.

Full description

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.

Enrollment

290 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.