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

Primary Purpose

Cancer Related Fatigue, Breast Cancer Female

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
American Ginseng
Placebo
Sponsored by
Network Italiano Cure di Supporto in Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Related Fatigue focused on measuring American Ginseng, Cancer related fatigue, Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Department, Perugia HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

American Ginseng

Placebo

Arm Description

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

Placebo: 1 cpr twice a day orally for 3 months

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 1, 2018
Last Updated
March 13, 2019
Sponsor
Network Italiano Cure di Supporto in Oncologia
Collaborators
Azienda Ospedaliera di Perugia, Associazione Umbra per la lotta Contro il Cancro, Avanti Tutta Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT03730298
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Network Italiano Cure di Supporto in Oncologia
Collaborators
Azienda Ospedaliera di Perugia, Associazione Umbra per la lotta Contro il Cancro, Avanti Tutta Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Fatigue, Breast Cancer Female
Keywords
American Ginseng, Cancer related fatigue, Breast Cancer Female

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind, placebo-controlled
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
American Ginseng
Arm Type
Experimental
Arm Description
American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: 1 cpr twice a day orally for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
American Ginseng
Intervention Description
cpr
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
cpr
Primary Outcome Measure Information:
Title
Incidence of cancer related fatigue during chemotherapy.
Description
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.
Title
Intensity of cancer related fatigue during chemotherapy.
Description
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.
Secondary Outcome Measure Information:
Title
Quality of Life (QoL)
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Oncology Department, Perugia Hospital
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fausto Roila, Dr
Phone
+39(0)755784099
Email
roila.fausto@libero.it
First Name & Middle Initial & Last Name & Degree
Sonia Fatigoni, Dr
Phone
+39(0)755784099
Email
fatisoni@libero.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24576643
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.
Results Reference
result
PubMed Identifier
19415341
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.
Results Reference
result
PubMed Identifier
23853057
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.
Results Reference
result

Learn more about this trial

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

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