Essiac (ESIAK) Versus Placebo to Improve Quality of Life in Transition in Women With Breast or Ovarian Cancer.
|ClinicalTrials.gov Identifier: NCT00287482|
Recruitment Status : Terminated
First Posted : February 6, 2006
Last Update Posted : February 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Breast Cancer||Drug: Essiac||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official 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.|
|Study Start Date :||October 2005|
|Study Completion Date :||July 2007|
- Quality of Life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287482
|United States, Rhode Island|
|Women & Infants' Hospital|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Don S Dizon, MD||Women & Infants' Hospital of Rhode Island|