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

June 21, 2011 updated by: Arizona Oncology Services

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Arizona Oncology Services
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically-confirmed diagnosis of breast (females only) or prostate cancer
  2. Zubrod performance status of 0-1.
  3. Patients must be ≥ 18 years of age.
  4. Scheduled to undergo definitive radiation therapy (either brachytherapy or external beam)
  5. Patients may have received or be receiving hormonal therapy. Prior chemotherapy is allowed as long as the patient has recovered from any toxicity. Planned future chemotherapy is also allowed after the one month evaluation.
  6. Hgb ≥ 10 g/dl, BUN < 25 mg and creatinine < 1.5 mg
  7. Patient must be able to comply with treatment regimen.
  8. Patient must complete the pre-treatment quality of life questionnaires.
  9. Women of childbearing potential must have a pre-treatment pregnancy test; women of childbearing potential and men able to father children must use non-hormonal-based birth control while on study.
  10. Patients must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Known allergies or reactions to Organic germanium
  2. Prior irradiation other than basal cell cancer of skin
  3. Current or past history of metastasis
  4. Current history of uncontrolled hypertension, insulin dependent or uncontrolled diabetes, cardiovascular disease unless controlled and stable for 6 months or more, bleeding disorders, or autoimmune disorders such as fibromyalgia, chronic fatigue syndrome or lupus
  5. Current use of corticosteroids or erythropoietin
  6. Patients currently taking Organic germanium, or who have taken Organic germanium within the past three months
  7. Pregnant or lactating women, as treatment involves unforeseeable risks to the participant and to the embryo or fetus
  8. Patients who are unable to complete quality of life questionnaires
  9. Male breast cancer patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Organic Germanium tablets 5 times a day
Dietary supplement: Organic Germanium
Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated
Other Names:
  • Allergy Research Group supplies the organic Germanium
Placebo Comparator: 2
Placebo tablets 3 -5 times per day
Dietary supplement: Placebo
Placebo tablets orally 3 - 5 times per day as tolerated
Other Names:
  • Allergy Research Group is supplying the placebo tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: One month pst treatment
One month pst treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit
Time Frame: One month follow up
One month follow up
To compare the duration of fatigue between organic germanium and placebo
Time Frame: One month follow up
One month follow up
To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.
Time Frame: one month follow up
one month follow up
To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer.
Time Frame: one month follow up
one month follow up
To determine when the patients recover from their radiation induced fatigue
Time Frame: 3 month follow-up
3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona Oncology Services

Investigators

  • Principal Investigator: Emily Grade, MD, Arizona Oncology Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Germanium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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