Essiac (ESIAK) Versus Placebo to Improve Quality of Life in Transition in Women With Breast or Ovarian Cancer.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00287482
• Date of registration: 03/02/2006
• Primary sponsor: Women and Infants Hospital of Rhode Island
• Public title: Essiac (ESIAK) Versus Placebo to Improve Quality of Life in Transition in Women With Breast or Ovarian Cancer.
• Scientific title: A Pilot Study of the Herbal Remedy Essiac (ESIAK ®) Versus Placebo in Improving the Quality of Life in Women Completing Adjuvant Treatment for Breast or Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers.
• Date of first enrolment: October 2005
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00287482
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Don S Dizon, MD
• Affiliation: Women & Infants' Hospital of Rhode Island

Key inclusion & exclusion criteria

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not part of normal medical care, with the understanding that consent may be withdrawn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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Ovarian Cancer

Intervention(s)

Drug: Essiac

Primary Outcome(s)

Quality of Life

Secondary Outcome(s)

Feasibility

Toxicity

Secondary ID(s)

WIH042005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors