Clinical trial NCT00293293: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Peritoneal Primary Cancer
Fallopian Tube Cancer
Keywords: stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Randy Shaver Cancer Research Fund
First posted: 2006-02-17
Enrollment: 43
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
timeFrame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
measure: Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Secondary outcomes:
measure: Number of Patients With Delays In Receiving Chemotherapy Alone
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Number of Patients With Delays In Receiving Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Anti-Emetic Dose Use After Chemotherapy Alone
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Natural Killer Cell Count Levels Before Chemotherapy Alone
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)
measure: Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
measure: Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
timeFrame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Moffitt
name: Patricia L. Judson, MD
role: STUDY_CHAIR
References: