NCT03730298

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

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).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Network Italiano Cure di Supporto in Oncologia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cancer Related Fatigue
• Breast Cancer Female

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	American Ginseng	cpr
OTHER	Placebo	cpr

Timeline

• Start date: 2018-11-29
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2018-11-05
• Last updated: 2019-03-15

Locations

1 site across 1 country: Italy