Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue

Localized Prostate Cancer Clinical Trial

Official title: A Phase II, Pilot, Randomized, Double-blind Study Comparing the Effectiveness Organic Germanium to Placebo in Decreasing the Severity of Fatigue in Patients Undergoing Radiation Therapy for Prostae and Bbreast Cancers

Status Recruiting

Clinical Trial Summary

Participants will be diagnosed with localized prostate or breast cancer and be scheduled to undergo external beam radiation therapy. Participants will either receive a placebo or organic germanium to be taken 5 times a day starting the day of their first radiation and continuing through the 1 month follow-up visit. Weekly Quality of life forms will be completed through the one month follow up visit and then at the 3 month follow up visit. Labs will be done prior to the start of treatment, at the end of treatment and at the one and three month follow-up visits.

Clinical Trial Description

With the increasing public use of complementary medicines, most researchers agree that there is a compelling need to study the safety and efficacy of these agents in humans by means of appropriately designed double-blind, placebo controlled clinical trials. With fatigue affecting 96% of the cancer patient population and little more than life style alterations offered as an intervention, the need to evaluate putative and innovative approaches for fatigue is a high priority. The NIH released a "State of the Science" statement in 2002 which concluded that fatigue is a serious cause of morbidity, being the most prevalent symptom experienced by cancer patients. This expert panel also concluded that the major barrier to effective management of fatigue includes a lack of awareness of this fact, the lack of knowledge of the causes of fatigue, and the lack of proven methods to treat fatigue. Presently, clinical trials evaluating intervention for cancer fatigue are lacking.

Organic germanium literature states that it may be an effective agent for combating fatigue with virtually no toxicities. Since virtually all cancer patients receiving radiation therapy experience fatigue, the use of this drug should be evaluated as an intervention for non-anemic fatigue in breast and prostate cancer patients undergoing a definitive course of radiation therapy. We intend to test whether organic germanium is able to reduce the fatigue experienced by patients undergoing radiation therapy and if this reduction in fatigue correlates to an improvement in quality of life for these patients. Changes in the patients' mood will also be evaluated. We will also collect information on the toxicity profile of Organic germanium and try to determine when the peak fatigue time occurs and possibly when they recover. This information will be utilized to see if a larger study is warranted.

2.0 OBJECTIVES 2.1 Primary: To determine if Organic germanium is effective in decreasing severity of fatigue in patients undergoing definitive radiation therapy for prostate or breast cancer at the one month follow-up visit.

2.2 Secondary 2.2.1 To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit 2.2.2 To compare the duration of fatigue between organic germanium and placebo 2.2.3 To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.

2.2.4 To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer.

2.2.5 To determine the tolerability of 5 tablets per day as the dosing schema. 2.2.6 To determine when the patients recover from their radiation induced fatigue ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Localized Breast Cancer
• Localized Prostate Cancer
• Patients Receiving External Beam Radiotherapy
• Prostatic Neoplasms

• NCT number: NCT00651417
• Study type: Interventional
• Source: Arizona Oncology Services
• Contact: Terry Thomas, MS, CCRC
• Phone: 602-240-3383
• Email: theresa@azoncology.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2005
• Completion date: December 2012