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Trial record 22 of 9039 for:    complementary OR alternative OR integrative AND therapy

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

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ClinicalTrials.gov Identifier: NCT00293293
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : June 6, 2012
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Randy Shaver Cancer Research Fund
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 43

Recruitment Details 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 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.
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. 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).
Period Title: Overall Study
Started 20 23
Completed 18 21
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Patient "too anxious" to complete trial             1             0
Patient discontinued chemotherapy             0             1
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM Total
Hide Arm/Group Description Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. 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 of all reporting groups
Overall Number of Baseline Participants 20 23 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 23 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  55.0%
16
  69.6%
27
  62.8%
>=65 years
9
  45.0%
7
  30.4%
16
  37.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 23 participants 43 participants
63.0  (11.4) 58.8  (11.8) 60.72  (11.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 23 participants 43 participants
Female
20
 100.0%
23
 100.0%
43
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 23 participants 43 participants
20 23 43
1.Primary Outcome
Title Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Mean (Full Range)
Unit of Measure: Scores on a Scale
Prior to Cycle 1
143
(121 to 200)
152
(138 to 187)
Prior to Cycle 3
154
(120 to 179)
152
(101 to 184)
Prior to Cycle 6
158
(141 to 188)
152
(119 to 200)
6 Months Post Chemotherapy (+/- 15 days)
173
(98 to 190)
162
(155 to 200)
2.Primary Outcome
Title Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Mean (Full Range)
Unit of Measure: Scores on a scale
Prior to Cycle 1
195
(141 to 209)
191
(165 to 230)
Prior to Cycle 3
182
(120 to 228)
189
(145 to 213)
Prior to Cycle 6
196
(141 to 222)
197
(166 to 230)
6 Months Post Chemotherapy (+/- 15 days)
203
(129 to 203)
187
(179 to 233)
3.Secondary Outcome
Title 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 DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
8
4.Secondary Outcome
Title 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 DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Plus CAM
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
7
5.Secondary Outcome
Title Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that received 6 cycles of chemotherapy alone.
Arm/Group Title Chemotherapy Alone
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Prescriptions per participant
4.75  (0.78)
6.Secondary Outcome
Title Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Chemotherapy Plus CAM
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Prescriptions per participant
5.95  (0.81)
7.Secondary Outcome
Title Average Anti-Emetic Dose Use After Chemotherapy Alone
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Dose (mg) per participant
453.2  (91.9)
8.Secondary Outcome
Title Average Anti-Emetic Dose Use After Chemotherapy Plus CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Plus CAM
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Dose (mg) per participant
604.2  (95.5)
9.Secondary Outcome
Title Average Natural Killer Cell Count Levels Before Chemotherapy Alone
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Overall Number of Participants Analyzed 20
Mean (Full Range)
Unit of Measure: Cells per mm^3
213
(141.3 to 257.4)
10.Secondary Outcome
Title Average Natural Killer Cell Count Levels Before Chemotherapy and CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Plus CAM
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 23
Mean (Full Range)
Unit of Measure: Cells per mm^3
244
(202.6 to 314.7)
11.Secondary Outcome
Title Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Measure Type: Number
Unit of Measure: Participants
2 3
12.Secondary Outcome
Title Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Measure Type: Number
Unit of Measure: Participants
5 6
13.Secondary Outcome
Title 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 DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
5653  (695.4) 6144  (839.3)
14.Secondary Outcome
Title Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
CD4 680  (58.0) 811  (82.6)
CD8 281  (30.4) 364  (34.5)
15.Secondary Outcome
Title Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description:
Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
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).
Overall Number of Participants Analyzed 20 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
14.07  (4.9) 8.66  (1.1)
Time Frame From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months)
Adverse Event Reporting Description Only Serious Adverse Events were collected in this study.
 
Arm/Group Title Chemotherapy Alone Chemotherapy + CAM
Hide Arm/Group Description Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. 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).
All-Cause Mortality
Chemotherapy Alone Chemotherapy + CAM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy Alone Chemotherapy + CAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      2/23 (8.70%)    
Gastrointestinal disorders     
Dehydration  2  0/20 (0.00%)  0 1/23 (4.35%)  1
Vomiting  2  0/20 (0.00%)  0 1/23 (4.35%)  1
Gastrointestinal  2  0/20 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations     
Infection/Febrile Neutropenia  2  0/20 (0.00%)  0 1/23 (4.35%)  1
Reproductive system and breast disorders     
Sexual/Reproductive Function  1  1/20 (5.00%)  1 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
2
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy Alone Chemotherapy + CAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Patricia L. Judson, M.D.
Organization: Moffitt Cancer Center
Phone: 813-745-1600
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00293293     History of Changes
Other Study ID Numbers: 2000NT790
UMN-WCC-30 ( Other Identifier: Women's Cancer Center, University of Minnesota )
0012M77821 ( Other Identifier: IRB, University of Minnesota )
First Submitted: February 16, 2006
First Posted: February 17, 2006
Results First Submitted: August 22, 2011
Results First Posted: June 6, 2012
Last Update Posted: December 28, 2017