Fatigue, malignant neoplasm of the breast.
Conditions
Interventions
Control group: 21 women with breast cancer at any stage of treatment will receive supplementation with guaraná (paullinia cupana) fractionated in 50 mg individual, to be consumed after breakfast and a
Dietary supplement
B01.650.940.800.575.912.250.885.722
Sponsors
Universidade Federal do Maranhão
Universidade Federal do Maranhão
Eligibility
Sex/Gender
Female
Age
30 Years to 59 Years
Inclusion criteria
Inclusion criteria: Individuals of the female gender; age group greater than or equal to 30 years and up to 59 years in any antineoplastic treatment; living in the city of São Luis. Disease stage I to III.
Exclusion criteria
Exclusion criteria: Men or women pregnant or in stage four of the disease. Age under 30 or greater than 59 years. Individuals who can not communicate verbally or move. With mental disorders; grade three to four nausea; anorexia or do not want to continue in the study or have any kind of complication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue assessment. For analysis of fatigue will be applied the Piper-Revised Fatigue Scale (EFP-R), which is composed of 22 items, which evaluates the largest number of symptom dimensions and are distributed in the following dimensions: 1- Behavioral (Questions 2 to 7 ); 2- Affective (Questions 8 to 12); 3- Sensory / psychological or sensory / cognitive / emotional (Questions 13 to 23) (MOTA, 2009). The total EFP-R score and dimensions are evaluated by the average of the respective items. The score of each question varies from 0 to 10, where 0 corresponds without fatigue and 10 the worst possible fatigue, being 1 to 3 = light fatigue, 4 to 6 = moderate fatigue and 7 to 10 = severe fatigue. It has international use, being translated and validated for Portuguese-Brazil (MOTA, 2008). Before and after treatment. The data will be expressed by mean and deviation in case of normality, median and first and third quartile in case of non-normal of means by Paired Test T or Wilcoxon and analysis of variance by Anova oneway independent with post hoc of bonferroni if ??parametric or Kruskal Wallis if non-parametric analysis with a variation of at least 5% in the pre and post intervention measurements.;Quality of Life will be assessed by EORTC BR 23 which is specific for patients with breast cancer. The EORTC BR 23 questionnaire consists of 23 questions that are divided into two groups: Functional scale that includes four items of body image; two items on sexual function; an item about sexual pleasure and an item about future perspective; Scale of symptoms consisting of seven items suffers the side effects of therapy; four items on the symptoms in the breast; three items about symptoms in the arm and an item about hair loss. | — |
Secondary
| Measure | Time frame |
|---|---|
| The dietary habits of the patients will be evaluated through the dual and alternating application of 24-hour Reminders - RD24 and Food Frequency Questionnaire - QFA. The 24-hour recall consists of a retrospective evaluation of food intake in the last 24 hours and the Food Frequency Questionnaire (FFQ) assesses the consumption of food groups. Both groups will be evaluated at baseline (T0) and at 12 weeks (T1) weeks of supplementation. Thus, the habitual food consumption of calories, macro and micronutrients will be estimated through these two days of RD24 and QFA. The application of the 24-hour Reminder to the participants of the experimental group will also serve to monitor the use of the supplement, and the QFA will analyze its food consumption throughout the months of follow-up.;Depression Assessment. The Beck Depression Inventory will be used to evaluate Depression. The inventory has translation and validation for Portuguese by Gorenstein and Andrade in 1998. Originally the instrument consists of 21 questions that indicate cognitive symptoms and somatic indicators of depression, having as results: minimum depression level (0-11); mild (12-19); moderate (20-35) and severe (36-63). However, the Short Form of the Beck Depression Inventory will use only the cognitive area that is sensitive and specific for individuals with some pathology (CANGUSSU, 2010; LOVE, 2004).Before and after treatment.The data will be expressed by mean and deviation in case of normality, median and first and third quartile in case of non-normal of means by the Paired Test T or Wilcoxon and analysis of variance by Anova oneway independent with post hoc of bonferroni if parametric or Kruskal Wallis if non-parametric analysis with a variation of at least 5% in the pre and post intervention measurements.;Analyze the quality of sleep. For sleep quality analysis, the Pittsburgh scale (PSQI-BR), validated for Portuguese / Brazil in 2008 by Bertolazi, will be used and consists of ten items ranging | — |
Countries
Brazil
Contacts
Public ContactDaise;João Batista de Araujo;Garcia
Universidade Federal do Maranhão;Universidade Federal do Maranhão
Outcome results
None listed