Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293293
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-02-16
Brief Title:
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-WCC-30 | OTHER | None | None |
| 0012M77821 | OTHER | IRB University of Minnesota | None |