Brief Title
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Official Title
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Brief Summary
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who
are undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy
and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed
epithelial ovarian, fallopian tube or peritoneal cavity cancer.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Secondary Outcome
Number of Patients With Delays In Receiving Chemotherapy Alone
Condition
Ovarian Cancer
Intervention
healing touch
Study Arms / Comparison Groups
Chemotherapy Alone
Description: Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
43
Start Date
May 2005
Completion Date
January 2010
Primary Completion Date
April 2009
Eligibility Criteria
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Patricia L. Judson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00293293
Organization ID
2000NT790
Secondary IDs
UMN-WCC-30
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Randy Shaver Cancer Research Fund
Study Sponsor
Patricia L. Judson, MD, Study Chair, Moffitt
Verification Date
December 2017