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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.

18 Years
90 Years
Not Enrolling
Ovarian Cancer, Breast Cancer

Thank you

Trial Information

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.

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 wide variety of behavioral (meditation, and spiritual practices) and clinical
(herbal, acupuncture, and massage) techniques. Patients with chronic diseases including
cancer tend to be very interested in these treatments and research involving CAM and their
ability to improve quality of life are needed.

Women transitioning from active treatment for breast or ovarian cancer to surveillance
(QOL-T) can experience physical and psychological distress, related to both treatment
(fatigue, alopecia, and menopausal symptoms), and the diagnosis itself. Intervention during
the critical time of transition from active therapy to follow-up may help patients to adjust
to life after cancer treatment.

Essiac has been documented to be a popular form of herbal treatment in patients with cancer.
Given its lack of reported side effects, we are interested in pursuing a formal evaluation
of a Essiac in capsule formulation (ESIAK) in women surviving breast or ovarian cancers to
evaluate its role in improving the overall quality of life following chemotherapy that often
accompanies the end of adjuvant therapy.

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not part of normal medical care, with the understanding that consent may be withdrawn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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Quality of Life

Principal Investigator

Don S Dizon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women & Infants' Hospital of Rhode Island


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

July 2007

Related Keywords:

  • Ovarian Cancer
  • Breast Cancer
  • Treatment side effects
  • Quality of Life
  • Transition
  • Survivorship
  • Breast Neoplasms
  • Ovarian Neoplasms



Women & Infants' HospitalProvidence, Rhode Island  02905