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

NCT00651417 | Unknown Phase 2 DMC

• 1 other identifier: Germanium
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Localized Breast Cancer; Localized Prostate Cancer; Patients Receiving External Beam Radiotherapy

Keywords

Organic germanium; fatigue; radiation therapy; breast cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  One month pst treatment

Secondary Outcomes (5)

• To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit

  One month follow up

• To compare the duration of fatigue between organic germanium and placebo

  One month follow up

• To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.

  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.

  one month follow up

• To determine when the patients recover from their radiation induced fatigue

  3 month follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Organic Germanium tablets 5 times a day

Dietary Supplement: Organic Germanium

2

PLACEBO COMPARATOR

Placebo tablets 3 -5 times per day

Dietary Supplement: Placebo

Interventions

Organic Germanium DIETARY_SUPPLEMENT

Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated

Also known as: Allergy Research Group supplies the organic Germanium

1

Placebo DIETARY_SUPPLEMENT

Placebo tablets orally 3 - 5 times per day as tolerated

Also known as: Allergy Research Group is supplying the placebo tablets.

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona Oncology Services: lead

Study Sites (1)

Arizona Oncology Services

Phoenix, Arizona, 85013, United States

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Fatigue; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Emily Grade, MD

  Arizona Oncology Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terry Thomas, MS, CCRC

CONTACT

602-240-3383; theresa@azoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

US (1)