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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Related Fatigue Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind, placebo-controlled

Study Groups

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American Ginseng

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

Group Type EXPERIMENTAL

American Ginseng

Intervention Type DIETARY_SUPPLEMENT

cpr

Placebo

Placebo: 1 cpr twice a day orally for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

cpr

Interventions

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American Ginseng

cpr

Intervention Type DIETARY_SUPPLEMENT

Placebo

cpr

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No