Fatigue, women, breast neoplasm.
Conditions
Interventions
There were three intervention groups:
1) Coco Babaçu Group (GCB) with n of 24 participants who received supplementation with babassu coconut oil (10ml orally twice daily with main meals (lunch and din
2) Beach coconut Group (GCP) with n of 24 participants and received supplementation with Coco's oil from Beach(10ml orally twice a day with main meals (lunch and dinner) for 12 weeks, in addition to c
3) Control Group (CG) with n of 24 participants and who did not receive any intervention other than hospital treatment.
Dietary supplement
SP6.051.227
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 greater than or equal to 30 and up to 59 years; in all anti-neoplastic treatment; not be using dietary supplementation for at least 3 months; stage IIA to IV of the disease.
Exclusion criteria
Exclusion criteria: Pregnant women, patients unable to communicate verbally and even to get around, mental disorders, use of mineral oil or lactulone, carriers of some biliary disease, use of hypocholesterolemic medication, not want to participate in all stages of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Assessment. For fatigue analysis, the Piper-Revised Fatigue Scale (EFP-R), which is composed of 22 items, evaluates the greatest number of symptom dimensions and is 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 overall EFP-R score and dimensions are evaluated by the mean 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, and has been 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 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.;Quality of life Assessment. Quality of Life was evaluated by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) questionnaire. Multidimensional, self-administered questionnaire consisting of 30 questions related to five functional (physical, functional, emotional, social and cognitive) scales, three symptom scales (fatigue, pain and nausea / vomiting), six additional symptom items (dyspnea, insomnia, loss of appetite, constipation, diarrhea and financial difficulties) and a scale on overall health status. The classification is done by linear transformation with a score ranging from 0 to 100. On the functional and global scale, the higher the score the better the quality of life and the symptom scale the higher the score, the worse the q | — |
Secondary
| Measure | Time frame |
|---|---|
| Food Consumption Assessment. The dietary habits of those evaluated will be estimated through the triple and alternate application of 24-hour Reminders (RD24), (APPENDIX D), which consists of a retrospective evaluation of the food intake in the last 24 hours. The quantification and standardization of home measures will be performed with the help of a photographic album proposed by Monteiro et.al, 2007). Thus, the usual food consumption of energy, macro and micronutrients will be estimated through the average of the three RD24. The application of RD24 to the participants of the groups will also serve as a follow-up to the supplementation used.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.;Cardiorespiratory Functional Assessment. For the evaluation of the cardiorespiratory functional capacity will be carried out the walk test of 6 minutes. The distance walked by the patient in 6 minutes reflects the physical capacity to perform day-to-day tasks (SOARES and PEREIRA, 2011). This test is widely used because of its low cost, easy application and good patient tolerance (PIRES et al., 2007). The patient will walk as much as he can for 6 minutes at the maximum possible speed. The following variables will be collected before and after the test: blood pressure, heart rate (HR) and level of dyspnea determined by the modified Borg scale (ATS, 2002). Test interruption criteria will be in accordance with the standards of the American Thoracic Society.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 | — |
Countries
Brazil
Contacts
Public ContactAlexsandro dos Santos
Universidade Federal do Maranhão
Outcome results
None listed