Multivitamins do Not Improve Radiation Therapy Related Fatigue

Breast Cancer Clinical Trial

Official title:

Multivitamins do Not Improve Radiation Therapy Related Fatigue: Results of a Double-Blind Randomized Cross-Over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383409
• Other study ID #: 199/2005
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2006
• Last updated: October 2, 2006
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2006
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 = 0.009; p = 0.001) and physical fatigue scores (p = 0.031; p = 0.029) at the end of the course of placebo compared to the assessment prior to this treatment. We also observed significant improvements in functional (p = 0.026) and symptoms (p = 0.016) 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 = 0.035 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• >18 years old

• breast cancer who were to receive radiation therapy to the breast after a conservative surgery or after mastectomy

Exclusion Criteria:

• previous history of radiation therapy,

• chronic anemia,

• depression

• serious psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• multivitamins

• placebo

Locations

Country	Name	City	State
Brazil	Instituto de Radioterapia do ABC – Av. Portugal, 592 –	Santo André	(sp)

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue
Secondary	quality of life