Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Primary Cancer
Conditions
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer
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.
Interventions
OTHERhealing touch
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.
OTHERmassage therapy
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.
OTHERhypnosis
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.
DRUGStandard chemotherapy
Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
Sponsors
Randy Shaver Cancer Research Fund
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | 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. |
| Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | 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 | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | 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 | 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. |
| Average Anti-Emetic Dose Use After Chemotherapy Plus CAM | 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. |
| Average Natural Killer Cell Count Levels Before Chemotherapy Alone | 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. |
| Number of Patients With Delays In Receiving Chemotherapy Alone | 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. |
| Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM | 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. |
| Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM | 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. |
| Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM | 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. |
| Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | 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). |
| Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM | 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. |
| Average Natural Killer Cell Count Levels Before Chemotherapy and CAM | 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. |
| Number of Patients With Delays In Receiving Chemotherapy Plus CAM | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Alone Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | 20 |
| 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). | 23 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient discontinued chemotherapy | 0 | 1 |
| Overall Study | Patient too anxious to complete trial | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Chemotherapy Alone | Chemotherapy + CAM |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 9 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 11 Participants | 16 Participants |
| Age, Continuous | 60.72 years STANDARD_DEVIATION 11.67 | 63.0 years STANDARD_DEVIATION 11.4 | 58.8 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 43 participants | 20 participants | 23 participants |
| Sex: Female, Male Female | 43 Participants | 20 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 20 | 2 / 23 |
Outcome results
Primary
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).
Time frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy + CAM | Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | 6 Months Post Chemotherapy (+/- 15 days) | 187 Scores on a scale |
| Chemotherapy + CAM | Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | Prior to Cycle 1 | 191 Scores on a scale |
| Chemotherapy + CAM | Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | Prior to Cycle 6 | 197 Scores on a scale |
| Chemotherapy + CAM | Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | Prior to Cycle 3 | 189 Scores on a scale |
Primary
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.
Time frame: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy Alone | 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 |
| Chemotherapy + CAM | Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | 6 Months Post Chemotherapy (+/- 15 days) | 162 Scores on a Scale |
| Chemotherapy + CAM | Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | Prior to Cycle 1 | 152 Scores on a Scale |
| Chemotherapy + CAM | Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | Prior to Cycle 6 | 152 Scores on a Scale |
| Chemotherapy + CAM | Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | Prior to Cycle 3 | 152 Scores on a Scale |
Secondary
Average Anti-Emetic Dose Use After Chemotherapy Alone
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Average Anti-Emetic Dose Use After Chemotherapy Alone | 453.2 Dose (mg) per participant | Standard Deviation 91.9 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Average Anti-Emetic Dose Use After Chemotherapy Plus CAM | 604.2 Dose (mg) per participant | Standard Deviation 95.5 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Chemotherapy Alone | Average Natural Killer Cell Count Levels Before Chemotherapy Alone | 213 Cells per mm^3 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Chemotherapy Alone | Average Natural Killer Cell Count Levels Before Chemotherapy and CAM | 244 Cells per mm^3 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
Population: Patients that received 6 cycles of chemotherapy alone.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone | 4.75 Prescriptions per participant | Standard Deviation 0.78 |
Secondary
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM | 5.95 Prescriptions per participant | Standard Deviation 0.81 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM | 14.07 mg/dL | Standard Deviation 4.9 |
| Chemotherapy + CAM | Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM | 8.66 mg/dL | Standard Deviation 1.1 |
Secondary
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).
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Alone | Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | CD4 | 680 cells/mm^3 | Standard Deviation 58 |
| Chemotherapy Alone | Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | CD8 | 281 cells/mm^3 | Standard Deviation 30.4 |
| Chemotherapy + CAM | Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | CD4 | 811 cells/mm^3 | Standard Deviation 82.6 |
| Chemotherapy + CAM | Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | CD8 | 364 cells/mm^3 | Standard Deviation 34.5 |
Secondary
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.
Time frame: Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Alone | Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM | 5653 cells/mm^3 | Standard Deviation 695.4 |
| Chemotherapy + CAM | Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM | 6144 cells/mm^3 | Standard Deviation 839.3 |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy Alone | Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM | 2 Participants |
| Chemotherapy + CAM | Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM | 3 Participants |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy Alone | Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM | 5 Participants |
| Chemotherapy + CAM | Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM | 6 Participants |
Secondary
Number of Patients With Delays In Receiving Chemotherapy Alone
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy Alone | Number of Patients With Delays In Receiving Chemotherapy Alone | 8 participants |
Secondary
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.
Time frame: Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy Alone | Number of Patients With Delays In Receiving Chemotherapy Plus CAM | 7 Participants |