Nausea
Conditions
Keywords
Nausea, Quality of life, Chemotherapy, Expectancy
Brief summary
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Detailed description
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.
Interventions
DEVICEAcupressure bands
Bilateral acupressure wrist bands
OTHERExpectancy-neutral handout
The expectancy neutral handout has neutral information regarding the acupressure bands
BEHAVIORALExpectancy-neutral MP3
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
OTHERExpectancy-enhancing handout
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
BEHAVIORALExpectancy-enhancing MP3
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be female. * Have a diagnosis of breast cancer, any stage. * Be chemotherapy naïve and about to begin her first course of chemotherapy. * Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are: 1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3. 2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3. 3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. 4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron. * Have a response of \> 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = I am certain I WILL NOT have this, and at the other end by 5 = I am certain I WILL have this. * Be able to read English (since the assessment materials are in printed format). * Be 18 years of age or older and give written informed consent.
Exclusion criteria
* Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist. * Be receiving concurrent radiotherapy or interferon.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Report Nausea Diary | five days | Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The outcome variable for the primary analysis was greatest reported nausea from the five day period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Patients will receive only standard care | 76 |
| Arm 2 * Handout without expectancy- enhancing component
* Relaxation MP3 without expectancy-enhancing component
* Acupressure bands | 75 |
| Arm 3 * Handout with expectancy- enhancing component
* Relaxation MP3 with expectancy-enhancing component
* Acupressure bands | 75 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Changed Medical Facility | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 3 |
| Overall Study | To ill to continue | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Arm 1 | Total | Arm 3 | Arm 2 |
|---|---|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 11.5 | 53 years STANDARD_DEVIATION 11.2 | 52.6 years STANDARD_DEVIATION 10.5 | 53.2 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 220 Participants | 73 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 19 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 67 Participants | 199 Participants | 66 Participants | 66 Participants |
| Region of Enrollment United States | 76 participants | 226 participants | 75 participants | 75 participants |
| Sex: Female, Male Female | 76 Participants | 226 Participants | 75 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 76 | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 | 0 / 75 |
Outcome results
Primary
Patient Report Nausea Diary
Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The outcome variable for the primary analysis was greatest reported nausea from the five day period.
Time frame: five days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Patient Report Nausea Diary | 3.87 units on a scale | Standard Deviation 2 |
| Expectancy-Neutral Condition | Patient Report Nausea Diary | 3.55 units on a scale | Standard Deviation 2 |
| Expectancy-Enhancing Condition | Patient Report Nausea Diary | 3.52 units on a scale | Standard Deviation 1.73 |
p-value: 0.05ANCOVA