Trial | NCT03730298  Report issue

Title

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).

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    290
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 Started
Nov 29
2018
Primary Completion
May 31
2020
Anticipated
Study Completion
Aug 31
2020
Anticipated
Last Update
Mar 15
2019

Dietary Supplement American Ginseng

cpr

Other Placebo

cpr

American Ginseng Experimental

American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months

Placebo Placebo Comparator

Placebo: 1 cpr twice a day orally for 3 months

Criteria 

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.
No Results Posted