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

March 13, 2019 updated by: Fausto Roila, Network Italiano Cure di Supporto in Oncologia

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).

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Perugia, Italy, 06100
        • Recruiting
        • Oncology Department, Perugia Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: American Ginseng
American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months
cpr
Placebo Comparator: Placebo
Placebo: 1 cpr twice a day orally for 3 months
cpr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cancer related fatigue during chemotherapy.
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.
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.
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.
These questionnaires will be administered at baseline (before randomization) and immediately before each chemotherapy cycle.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Female

Clinical Trials on American Ginseng

Subscribe