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

This study has been completed.
Sponsor:
Collaborator:
Randy Shaver Cancer Research Fund
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00293293
First received: February 16, 2006
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
Results First Received: August 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Ovarian Cancer
Peritoneal Primary Cancer
Fallopian Tube Cancer
Interventions: Other: healing touch
Other: massage therapy
Other: hypnosis
Drug: Standard chemotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients made informed consent and were randomized to chemotherapy alone or chemotherapy with complementary alternative medicine (hypnosis, massage, healing touch). Patients received either intravenous paclitaxel and carboplatin on an every 3 week basis, or a combination of intravenous and intraperitoneal paclitaxel and cisplatin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Analysis was conducted as intent-to-treat. All randomized patients were included, regardless of number of courses of chemotherapy, CAM therapy or survival. All women in the CAM arm of the trial received all prescribed CAM interventions. No investigational drugs were administered as a part of this protocol.

Reporting Groups
  Description
Chemotherapy Alone Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Chemotherapy + CAM Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).

Participant Flow:   Overall Study
    Chemotherapy Alone     Chemotherapy + CAM  
STARTED     20     23  
COMPLETED     18     21  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 1  
Patient "too anxious" to complete trial                 1                 0  
Patient discontinued chemotherapy                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Chemotherapy Alone Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Chemotherapy + CAM Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
Total Total of all reporting groups

Baseline Measures
    Chemotherapy Alone     Chemotherapy + CAM     Total  
Number of Participants  
[units: participants]
 		  20     23     43  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     16     27  
>=65 years     9     7     16  
Age  
[units: years]
Mean ± Standard Deviation 		  63.0  ± 11.4     58.8  ± 11.8     60.72  ± 11.67  
Gender  
[units: participants]
 		     
Female     20     23     43  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     20     23     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)   [ Time Frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy ]
  Show Outcome Measure 1

2.  Primary:   Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy ]
  Show Outcome Measure 2

3.  Secondary:   Number of Patients With Delays In Receiving Chemotherapy Alone   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Patients With Delays In Receiving Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 4

5.  Secondary:   Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 5

6.  Secondary:   Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 6

7.  Secondary:   Average Anti-Emetic Dose Use After Chemotherapy Alone   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 7

8.  Secondary:   Average Anti-Emetic Dose Use After Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chemotherapy Plus CAM Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).

Measured Values
    Chemotherapy Plus CAM  
Number of Participants Analyzed  
[units: participants]
 		  23  
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM  
[units: Dose (mg) per participant]
Mean ± Standard Deviation 		  604.2  ± 95.5  

No statistical analysis provided for Average Anti-Emetic Dose Use After Chemotherapy Plus CAM



9.  Secondary:   Average Natural Killer Cell Count Levels Before Chemotherapy Alone   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 9

10.  Secondary:   Average Natural Killer Cell Count Levels Before Chemotherapy and CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 10

11.  Secondary:   Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 11

12.  Secondary:   Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 12

13.  Secondary:   Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months) ]
  Show Outcome Measure 13

14.  Secondary:   Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 14

15.  Secondary:   Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM   [ Time Frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Patricia L. Judson, M.D.
Organization: Moffitt Cancer Center
phone: 813-745-1600
e-mail: Patricia.Judson@moffitt.org


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00293293     History of Changes
Other Study ID Numbers: 2000NT790, UMN-WCC-30, 0012M77821
Study First Received: February 16, 2006
Results First Received: August 22, 2011
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board