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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Quality of Life
Don S Dizon, MD
Women & Infants' Hospital of Rhode Island
United States: Food and Drug Administration
|Women & Infants' Hospital||Providence, Rhode Island 02905|