Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT00293293
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Sponsor:
Masonic Cancer Center, University of Minnesota
Organization:
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:
False
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?: