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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Localized Breast Cancer, Localized Prostate Cancer, Patients Receiving External Beam Radiotherapy

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

One month pst treatment

Safety Issue:

No

Principal Investigator

Emily Grade, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Arizona Oncology Services

Authority:

United States: Institutional Review Board

Study ID:

Germanium

NCT ID:

NCT00651417

Start Date:

April 2005

Completion Date:

December 2012

Related Keywords:

  • Localized Breast Cancer
  • Localized Prostate Cancer
  • Patients Receiving External Beam Radiotherapy
  • Organic germanium
  • fatigue
  • radiation therapy
  • breast cancer
  • prostate cancer
  • Breast Neoplasms
  • Fatigue
  • Prostatic Neoplasms

Name

Location

Arizona Oncology ServicesPhoenix, Arizona  85032