Trial Outcomes & Findings for Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine (NCT NCT00293293)

NCT ID: NCT00293293

Last Updated: 2017-12-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
• Results posted on: 2017-12-28

Participant Flow

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.

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.

Participant milestones

Measure	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).
Overall Study STARTED	20	23
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	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).
Overall Study Withdrawal by Subject	1	1
Overall Study Patient "too anxious" to complete trial	1	0
Overall Study Patient discontinued chemotherapy	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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 n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	63.0 years STANDARD_DEVIATION 11.4 • n=5 Participants	58.8 years STANDARD_DEVIATION 11.8 • n=7 Participants	60.72 years STANDARD_DEVIATION 11.67 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	23 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy

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.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) Prior to Cycle 1	143 Scores on a Scale Interval 121.0 to 200.0	152 Scores on a Scale Interval 138.0 to 187.0
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) Prior to Cycle 3	154 Scores on a Scale Interval 120.0 to 179.0	152 Scores on a Scale Interval 101.0 to 184.0
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) Prior to Cycle 6	158 Scores on a Scale Interval 141.0 to 188.0	152 Scores on a Scale Interval 119.0 to 200.0
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) 6 Months Post Chemotherapy (+/- 15 days)	173 Scores on a Scale Interval 98.0 to 190.0	162 Scores on a Scale Interval 155.0 to 200.0

PRIMARY outcome

Timeframe: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy

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).

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM Prior to Cycle 1	195 Scores on a scale Interval 141.0 to 209.0	191 Scores on a scale Interval 165.0 to 230.0
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM Prior to Cycle 3	182 Scores on a scale Interval 120.0 to 228.0	189 Scores on a scale Interval 145.0 to 213.0
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM Prior to Cycle 6	196 Scores on a scale Interval 141.0 to 222.0	197 Scores on a scale Interval 166.0 to 230.0
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM 6 Months Post Chemotherapy (+/- 15 days)	203 Scores on a scale Interval 129.0 to 203.0	187 Scores on a scale Interval 179.0 to 233.0

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Number of patients who had to delay their chemotherapy treatments due to side effects.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants 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).
Number of Patients With Delays In Receiving Chemotherapy Alone	8 participants	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.

Outcome measures

Measure	Chemotherapy Alone n=23 Participants 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).
Number of Patients With Delays In Receiving Chemotherapy Plus CAM	7 Participants	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Population: Patients that received 6 cycles of chemotherapy alone.

Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants 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).
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone	4.75 Prescriptions per participant Standard Deviation 0.78	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Population: 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).

Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.

Outcome measures

Measure	Chemotherapy Alone n=23 Participants 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).
Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM	5.95 Prescriptions per participant Standard Deviation 0.81	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants 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).
Average Anti-Emetic Dose Use After Chemotherapy Alone	453.2 Dose (mg) per participant Standard Deviation 91.9	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.

Outcome measures

Measure	Chemotherapy Alone n=23 Participants 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).
Average Anti-Emetic Dose Use After Chemotherapy Plus CAM	604.2 Dose (mg) per participant Standard Deviation 95.5	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

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.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants 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).
Average Natural Killer Cell Count Levels Before Chemotherapy Alone	213 Cells per mm^3 Interval 141.3 to 257.4	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

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.

Outcome measures

Measure	Chemotherapy Alone n=23 Participants 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).
Average Natural Killer Cell Count Levels Before Chemotherapy and CAM	244 Cells per mm^3 Interval 202.6 to 314.7	—

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

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.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)

Determined from white blood cell counts collected during treatment phase of study; average applied.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM	5653 cells/mm^3 Standard Deviation 695.4	6144 cells/mm^3 Standard Deviation 839.3

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

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).

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM CD4	680 cells/mm^3 Standard Deviation 58.0	811 cells/mm^3 Standard Deviation 82.6
Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM CD8	281 cells/mm^3 Standard Deviation 30.4	364 cells/mm^3 Standard Deviation 34.5

SECONDARY outcome

Timeframe: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)

Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.

Outcome measures

Measure	Chemotherapy Alone n=20 Participants Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 Participants 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).
Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM	14.07 mg/dL Standard Deviation 4.9	8.66 mg/dL Standard Deviation 1.1

Adverse Events

Chemotherapy Alone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemotherapy + CAM

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chemotherapy Alone n=20 participants at risk Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.	Chemotherapy + CAM n=23 participants at risk 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).
Reproductive system and breast disorders Sexual/Reproductive Function	5.0% 1/20 • Number of events 1 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.	0.00% 0/23 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.
Gastrointestinal disorders Dehydration	0.00% 0/20 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.	4.3% 1/23 • Number of events 1 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.
Gastrointestinal disorders Vomiting	0.00% 0/20 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.	4.3% 1/23 • Number of events 1 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.
Infections and infestations Infection/Febrile Neutropenia	0.00% 0/20 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.	4.3% 1/23 • Number of events 1 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.
Gastrointestinal disorders Gastrointestinal	0.00% 0/20 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.	4.3% 1/23 • Number of events 1 • From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months) Only Serious Adverse Events were collected in this study.

Other adverse events

Adverse event data not reported

Additional Information

Patricia L. Judson, M.D.

Moffitt Cancer Center

Phone: 813-745-1600

Email: Patricia.Judson@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place