Clinical trial NCT03730298: American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Related Fatigue
Breast Cancer Female
Keywords: American Ginseng
Cancer related fatigue
Breast Cancer Female
Lead sponsor: Network Italiano Cure di Supporto in Oncologia
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Perugia
name: Associazione Umbra per la lotta Contro il Cancro
name: Avanti Tutta Onlus
First posted: 2018-11-05
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of cancer related fatigue during chemotherapy.
timeFrame: 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.
measure: Intensity of cancer related fatigue during chemotherapy.
timeFrame: 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 outcomes:
measure: Quality of Life (QoL)
timeFrame: These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Oncology Department, Perugia Hospital
Study officials:
References:
citation: Koornstra RH, Peters M, Donofrio S, van den Borne B, de Jong FA. Management of fatigue in patients with cancer -- a practical overview. Cancer Treat Rev. 2014 Jul;40(6):791-9. doi: 10.1016/j.ctrv.2014.01.004. Epub 2014 Feb 7.
citation: Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6.
citation: Barton DL, Liu H, Dakhil SR, Linquist B, Sloan JA, Nichols CR, McGinn TW, Stella PJ, Seeger GR, Sood A, Loprinzi CL. Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. J Natl Cancer Inst. 2013 Aug 21;105(16):1230-8. doi: 10.1093/jnci/djt181. Epub 2013 Jul 13.