Advertisement

Topics

Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue

2014-08-27 03:16:52 | BioPortfolio

Summary

The investigators hypothesize that Guaraná, a native plant from the Amazon, might improve chemotherapy-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, the investigators randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the cycles of Chemotherapy.

Description

The aim of this study is evaluate the favourable effects of Guaraná in quality of life and Fatigue in patients undergoing Chemotherapy treatment for Breast Cancer. After approval by our Institutional Review Board, we included consenting patients with a histological diagnosis of Breast Cancer for whom Chemotherapy was indicated.

Patients who agreed to participate in the study were submitted initially to a screening interview with the Brief Fatigue Inventory questionnaire from MD Anderson. If the patient presented with a severe fatigue, anemia (HB<11.0), hypothyroidism or psychiatric disorders she was excluded. If she presented with a mild or moderate fatigue the follow up continued and the patient was assessed 21 days later after her first cycle of chemotherapy with the same questionnaire. If an increase in fatigue levels occurred from mild to moderate, mild to severe or moderate to severe the patient was randomly assigned to receive either Guaraná 50mg or a placebo p.o. q12 for 21 days. At this moment the patient answered a General questionnaire, FACIT-F, FACIT-ES, HADS, Pittsburgh Sleep Quality Index and Chalder Fatigue Questionnaire (Day 1).

After the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days without any intervention, and after that period she received placebo or Guaraná according to the cross over design after answering for the second time the questionnaires above (Day 29) and also the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). After 21 days (Day 42) she was assessed again with the same questionnaires used in the second interview.

The patient's cancer diagnosis, treatment history, concurrent medication was recorded during the pretreatment and The Brief Fatigue Inventory was answered before each assessment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Signs and Symptoms

Intervention

Guarana extract

Location

Faculdade de Medicina do ABC
Santo Andre
SP
Brazil
09060650

Status

Completed

Source

Faculdade de Medicina do ABC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:52-0400

Clinical Trials [751 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy Study of rEV131 in Allergic Rhinitis

The purpose of this study is to see whether rEV131 when given as a nasal spray in a single dose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hay feve...

Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In High Risk Patients With Influenza

This research is being done to determine if an extract of cooked elderberries will help decrease the duration and severity of influenza symptoms in patients who are at high risk of severe ...

A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, d...

Evaluation of Heart Failure Treatment Guided by NTproBNP vs Clinical Symptoms and Signs Alone

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patien...

Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis

Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been sh...

PubMed Articles [6920 Associated PubMed Articles listed on BioPortfolio]

Anti-Aging and Antioxidant Potential of Paullinia cupana var. sorbilis: Findings in Caenorhabditis elegans Indicate a New Utilization for Roasted Seeds of Guarana.

Background: Roasted seeds of Amazonian guarana (Paullinia cupana var. sorbilis; Sapindaceae) are popular in South America due to their stimulant activity on the central nervous system (CNS). Rich in p...

The effect of Guarana (Paullinia cupana) on metabolic and inflammatory parameters in adult male mice programmed by maternal obesity.

Maternal obesity can program the offspring, increasing the risk of overweight and obesity in adult life. Guarana (Paullinia cupana) is a Brazilian plant that has weight-reducing effects. Thus, this st...

A proteomic approach to guarana seed and pericarp maturation.

Paullinia cupana Kunth var. sorbilis (Mart.) Ducke, the cultivated guarana plant, is native to the Amazon and has been valued for its medicinal, stimulant and energetic properties for centuries. The s...

Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis: Text mining of the Japanese postmarketing adverse event-reporting database.

To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients.

Amyotrophic lateral sclerosis presenting as the temporomandibular disorder: A case report and literature review.

Spasticity and pain in the masticatory muscles or mouth opening limitation have been reported as early signs and symptoms of amyotrophic lateral sclerosis (ALS). These signs and symptoms are also freq...

Medical and Biotech [MESH] Definitions

A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.

A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-IV)

Clinical manifestations that can be either objective when observed by a physician, or subjective when perceived by the patient.

Clinical signs and symptoms caused by nervous system injury or dysfunction.

A plant genus of the family SAPINDACEAE. The seed of P. cupana is the source of guarana powder which contains 4% CAFFEINE.

More From BioPortfolio on "Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial