N/A
N=242
Alternative Approaches for Nausea Control
Nausea
Bottom Line
View on ClinicalTrials.gov: NCT01695993 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Patient Report Nausea Diary — 3.87; 3.55; 3.52 units on a scale — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupressure bands (Device); Expectancy-neutral handout (Other); Expectancy-neutral MP3 (Behavioral); Expectancy-enhancing handout (Other); Expectancy-enhancing MP3 (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Report Nausea Diary |
3.87; 3.55; 3.52 | .05 |
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
Eligibility Criteria
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:
- Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
- Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
- Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
- 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.
Data sourced from ClinicalTrials.gov (NCT01695993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.