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Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine

Primary Purpose

Ovarian Cancer, Peritoneal Primary Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
healing touch
massage therapy
hypnosis
Standard chemotherapy
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center at University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy Alone

Standard Chemotherapy + CAM

Arm 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.

Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.

Outcomes

Primary Outcome Measures

Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
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.
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).

Secondary Outcome Measures

Number of Patients With Delays In Receiving Chemotherapy Alone
Number of patients who had to delay their chemotherapy treatments due to side effects.
Number of Patients With Delays In Receiving Chemotherapy Plus CAM
Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.
Average Anti-Emetic Dose Use After Chemotherapy Alone
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.
Average Natural Killer Cell Count Levels Before Chemotherapy Alone
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.
Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.
Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM
Determined from white blood cell counts collected during treatment phase of study; average applied.
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).
Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.

Full Information

First Posted
February 16, 2006
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Randy Shaver Cancer Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00293293
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Randy Shaver Cancer Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy Alone
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Chemotherapy + CAM
Arm Type
Experimental
Arm Description
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.
Intervention Type
Other
Intervention Name(s)
healing touch
Other Intervention Name(s)
energy-based therapy
Intervention Description
The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
Intervention Type
Other
Intervention Name(s)
massage therapy
Other Intervention Name(s)
massage
Intervention Description
Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
Intervention Type
Other
Intervention Name(s)
hypnosis
Other Intervention Name(s)
mind-body intervention procedure
Intervention Description
Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Other Intervention Name(s)
Taxane, Platinum
Intervention Description
Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
Primary Outcome Measure Information:
Title
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
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.
Time Frame
Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Title
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).
Time Frame
Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Secondary Outcome Measure Information:
Title
Number of Patients With Delays In Receiving Chemotherapy Alone
Description
Number of patients who had to delay their chemotherapy treatments due to side effects.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Number of Patients With Delays In Receiving Chemotherapy Plus CAM
Description
Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
Description
Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
Description
Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Anti-Emetic Dose Use After Chemotherapy Alone
Description
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Description
Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Natural Killer Cell Count Levels Before Chemotherapy Alone
Description
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
Description
Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
Determined from white blood cell counts collected during treatment phase of study; average applied.
Time Frame
Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)
Title
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Title
Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
Description
Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.
Time Frame
Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia L. Judson, MD
Organizational Affiliation
Moffitt
Official's Role
Study Chair
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine

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