Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
- Determine whether quality of life is improved in patients with epithelial ovarian,
fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy,
and healing touch and standard chemotherapy as compared to patients receiving standard
- Determine changes in immunologic response markers, chemotherapy side effects, and
complication rates in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial
ovarian, fallopian tube or primary peritoneal cancer.
- Arm II (standard therapy with complementary alternative medicine): Patients undergo
chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes
and healing touch therapy over approximately 30 minutes with each course of
chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.
Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6
months after completion of study treatment.
After completion of study treatment, patients are followed at 6 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Measured by Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.
Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Patricia L. Judson, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|