Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383409
Status:
COMPLETED
Last Update Posted:
2006-10-03
First Post:
2006-10-02
Brief Title:
Multivitamins do Not Improve Radiation Therapy Related Fatigue
Sponsor:
Faculdade de Medicina do ABC
Organization:
Faculdade de Medicina do ABC
Study Overview
Official Title:
Multivitamins do Not Improve Radiation Therapy Related Fatigue Results of a Double-Blind Randomized Cross-Over Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multivitamins MVi are broadly used by cancer patients to improve overall health and energy Fatigue is a common symptom in cancer patients including those receiving radiation therapy We conducted a trial of MVi versus placebo in patients with breast cancer BC undergoing radiation therapy Rxt to evaluate if MVi would affect fatigue and quality of life We randomized patients at the beginning of Rxt treatment to either placebo or Centrum Silver Wyeth-Whitehall laboratory At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa Patients answered to the EORTC QLQ C-30 quality of life QOL and Chalder Fatigue Questionnaires at the beginning the time of switching and at the end of Rxt We found that both groups experienced significant decreases in general and physical fatigue at the end of the course of placebo compared to the assessment prior to this treatment We also observed significant improvements in functional and symptoms in the patients on placebo When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi We conclude that MVi do not improve radiation related fatigue and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt
Detailed Description:
Multivitamins MVi are broadly used by cancer patients to improve overall health and energy Fatigue is a common symptom in cancer patients including those receiving radiation therapy We conducted a double blind randomized cross-over trial of MVi versus placebo in patients with breast cancer BC undergoing radiation therapy Rxt to evaluate if MVi would affect fatigue and quality of life We randomized forty patients at the beginning of Rxt treatment to either placebo or Centrum Silver Wyeth-Whitehall laboratory At the middle of the radiation treatments patients were switched from placebo to MVi and vice versa Patients answered to the EORTC QLQ C-30 quality of life QOL and Chalder Fatigue Questionnaires at the beginning the time of switching and at the end of Rxt When we analyzed the same group of patients throughout the treatment periods we found that both groups experienced significant decreases in general p 0009 p 0001 and physical fatigue scores p 0031 p 0029 at the end of the course of placebo compared to the assessment prior to this treatment We also observed significant improvements in functional p 0026 and symptoms p 0016 score scales of the QOL questionnaire in the patients on placebo No significant changes were elicited with the use of MVi When we compared different groups of patients we also observed significantly lower rates of physical and general fatigue in the patients who had just finished a course of placebo as compared to patients finishing course of MVi 0 vs 25 p 0035 for both types of fatigue We conclude that MVi do not improve radiation related fatigue and may in fact have a deleterious effect on fatigue and decrease QOL in patients with BC undergoing Rxt Further studies are needed to confirm our findings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None