Multivitamins do Not Improve Radiation Therapy Related Fatigue

NCT00383409 | Completed Phase 2

• 1 other identifier: 199/2005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast; cancer; fatigue; multivitamins

Outcome Measures

Primary Outcomes (1)

• fatigue

Secondary Outcomes (1)

• quality of life

Interventions

multivitamins DRUG

placebo DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• breast cancer who were to receive radiation therapy to the breast after a conservative surgery or after mastectomy

You may not qualify if:

• previous history of radiation therapy,
• chronic anemia,
• depression
• serious psychiatric disorders

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Instituto de Radioterapia do ABC - Av. Portugal, 592 -

Santo André, São Paulo, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Fatigue

Interventions

Geritol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Auro Del Giglio, MD

  FM-ABC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 3, 2006
• Study Start: March 1, 2006
• Study Completion: August 1, 2006
• Last Updated: October 3, 2006

Record last verified: 2006-10

Locations

BR (1)