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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
290
cpr
cpr
Oncology Department, Perugia Hospital
Perugia, Italy
RECRUITINGIncidence 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).
Time frame: 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.
Time frame: 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.
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.
Time frame: These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.