Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
N/A
N/A
Female
Ovarian Cancer, Peritoneal Primary Cancer, Fallopian Tube Cancer
Trial Information
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
OBJECTIVES:
Primary
- 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
chemotherapy alone.
Secondary
- 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.
Inclusion Criteria:
- Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any
pathologic type or stage, who will receive 6 cycles of chemotherapy.
- Patients must have signed an informed consent
Exclusion Criteria:
- Previous cancer other than skin cancer
- Previous chemotherapy experience
- Active substance abuse
- Schizophrenia
- Pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Outcome Description:
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.
Outcome Time Frame:
Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Safety Issue:
No
Principal Investigator
Patricia L. Judson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2000NT790
NCT ID:
NCT00293293
Start Date:
May 2005
Completion Date:
January 2010
Related Keywords:
- Ovarian Cancer
- Peritoneal Primary Cancer
- Fallopian Tube Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- peritoneal cavity cancer
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
