Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue - Full Text View

Sponsor:	Arizona Oncology Services
Information provided by:	Arizona Oncology Services
ClinicalTrials.gov Identifier:	NCT00651417

Purpose

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.

Condition	Intervention	Phase
Localized Breast Cancer Localized Prostate Cancer Patients Receiving External Beam Radiotherapy	Dietary Supplement: Organic Germanium Dietary Supplement: Placebo	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Allergy Breast Cancer Cancer Fatigue Prostate Cancer

U.S. FDA Resources

Further study details as provided by Arizona Oncology Services:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit [ Time Frame: One month follow up ] [ Designated as safety issue: No ]
To compare the duration of fatigue between organic germanium and placebo [ Time Frame: One month follow up ] [ Designated as safety issue: No ]
To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale. [ Time Frame: one month follow up ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
To determine when the patients recover from their radiation induced fatigue [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	101
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Allergy Research Group is supplying the placebo tablets.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically-confirmed diagnosis of breast (females only) or prostate cancer
Zubrod performance status of 0-1.
Patients must be ≥ 18 years of age.
Scheduled to undergo definitive radiation therapy (either brachytherapy or external beam)
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.
Hgb ≥ 10 g/dl, BUN < 25 mg and creatinine < 1.5 mg
Patient must be able to comply with treatment regimen.
Patient must complete the pre-treatment quality of life questionnaires.
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.
Patients must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

Known allergies or reactions to Organic germanium
Prior irradiation other than basal cell cancer of skin
Current or past history of metastasis
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
Current use of corticosteroids or erythropoietin
Patients currently taking Organic germanium, or who have taken Organic germanium within the past three months
Pregnant or lactating women, as treatment involves unforeseeable risks to the participant and to the embryo or fetus
Patients who are unable to complete quality of life questionnaires
Male breast cancer patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651417

Contacts

Contact: Terry Thomas, MS, CCRC

602-240-3383

theresa@azoncology.com

Locations

United States, Arizona
Arizona Oncology Services	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Terry Thomas, MS, CCRC 602-240-3383 theresa@azoncology.com

Sponsors and Collaborators

Arizona Oncology Services

Investigators

Principal Investigator:

Emily Grade, MD

Arizona Oncology Services

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Emily Grade,M.D., Principal Investigator, Arizona Oncology Serivces Foundation
ClinicalTrials.gov Identifier:	NCT00651417 History of Changes
Other Study ID Numbers:	Germanium
Study First Received:	March 31, 2008
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Arizona Oncology Services:

Organic germanium
fatigue
radiation therapy
breast cancer
prostate cancer

Additional relevant MeSH terms:

Breast Neoplasms
Fatigue
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases

Skin Diseases
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2012