Status:
TERMINATED
Essiac (ESIAK) Versus Placebo to Improve Quality of Life in Transition in Women With Breast or Ovarian Cancer.
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
This is a pilot feasibility study being performed in women completing front-line treatment for breast or ovarian cancer. It is being done to evaluate whether or not an herbal combination known as Essi...
Detailed Description
Complementary and Alternative medical (CAM) practices are "healthcare practices outside the realm of conventional medicine, which are yet to be validated using scientific methods". It encompasses a wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- histologically documented diagnosis of infiltrating carcinoma of the breast or epithelial ovarian cancer. Given the similar clinical course of patients with fallopian tube and primary peritoneal carcinoma these patients will also be included in the study.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients must be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Women of child-bearing potential must have a negative pregnancy test. If patients become pregnant during the course of the study, they will not be allowed to continue on the study.
- age ≥ 18 year-old
- Karnofsky performance status \> 70%
- Ability to understand and willingness to sign informed consent
- Ability to perform and comply with follow-up on study
- No history of drug or alcohol abuse
- No antecedent history of depression prior to diagnosis of malignancy
- Must be ≥ 4 weeks from completion of chemotherapy or radiation therapy.
- Adequate hematopoietic function defined as: ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.
- Adequate renal and hepatic function defined as: Bilirubin ≤ 1.5 times upper limit of normal (ULN); SGOT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; Creatinine ≤ 2 times ULN.
- For patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC/FT/PPC): patients must have completed front-line treatment within 3 months of study entry and in a complete remission; Patients treated with neoadjuvant platinum-based chemotherapy prior to definitive surgery will be eligible; If serum CA-125 was elevated at diagnosis, it must also have normalized by end of treatment.
- For patients with breast cancer: patients must have completed adjuvant treatment with chemotherapy and radiation therapy (if recommended) within three months of study entry and deemed in complete remission; Treatment must have included adjuvant chemotherapy and radiation if recommended; Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated. Patients receiving hormonal therapy following chemotherapy will be eligible to participate. However, patients placed on Tamoxifen or other hormonal agents in lieu of chemotherapy will not be eligible.
- Exclusion Criteria
- history or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers
- residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematologic toxicity
- they are unable to give informed consent
- they are unable to adhere to protocol
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- concurrent uncontrolled illness
- ongoing or active infection
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00287482
Start Date
October 1 2005
End Date
July 1 2007
Last Update
February 12 2007
Active Locations (1)
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1
Women & Infants' Hospital
Providence, Rhode Island, United States, 02905