Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | December 22, 2009 | ||||||||
| Last Updated Date | January 6, 2010 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Fatigue improvement between the baseline to D21 or from D21 to D42 measured by Chalder Fatigue Scale, FACT-F and FACT-ES questionnaires [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01043913 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To access the quality of life between the baseline to D21 or from D21 to D42 measured by FACT-F and FACT ES questionnaires [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Guarana (Paullinia Cupana) for Breast Cancer Chemotherapy-related Fatigue | ||||||||
| Official Title ICMJE | Guaraná ("Paullinia Cupana") for Chemotherapy Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study | ||||||||
| Brief 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. |
||||||||
| Detailed 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 Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Drug: Guarana extract
Guarana extract 50mg q12 hours for 21 days
Other Name: Paullinia Cupana |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01043913 | ||||||||
| Other Study ID Numbers ICMJE | mairapaschoin | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Auro Del Giglio, MD, PhD, ABC Foundation School of Medicine | ||||||||
| Study Sponsor ICMJE | Faculdade de Medicina do ABC | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Faculdade de Medicina do ABC | ||||||||
| Verification Date | November 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||