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

NCT03730298 | Unknown

• 1 other identifier: NICSO-GINSENG
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Related Fatigue; Breast Cancer Female

Keywords

American Ginseng; Cancer related fatigue; Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• Incidence 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).

  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.

  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 (1)

• Quality of Life (QoL)

  These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.

Study Arms (2)

American Ginseng

EXPERIMENTAL

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

Dietary Supplement: American Ginseng

Placebo

PLACEBO COMPARATOR

Placebo: 1 cpr twice a day orally for 3 months

Other: Placebo

Interventions

American Ginseng DIETARY_SUPPLEMENT

cpr

American Ginseng

Placebo OTHER

cpr

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• year old, who have given written informermed consent;
• who accept to use adequate contraceptive methods, if they are of child-bearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Network Italiano Cure di Supporto in Oncologia: lead
• Azienda Ospedaliera di Perugia: collaborator
• Associazione Umbra per la lotta Contro il Cancro: collaborator
• Avanti Tutta Onlus: collaborator

Study Sites (1)

Oncology Department, Perugia Hospital

Perugia, 06100, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 24576643 RESULT

• 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.

  PMID: 19415341 RESULT

• 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.

  PMID: 23853057 RESULT

MeSH Terms

Interventions

Asian ginseng

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 29, 2018
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)