Clinical trial NCT01695993: Alternative Approaches for Nausea Control
Official title: Alternative Approaches for Nausea Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Keywords: Nausea
Quality of life
Chemotherapy
Expectancy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-09-28
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

  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.

Primary outcomes:
measure: Patient Report Nausea Diary
timeFrame: five days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of Central New York
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital's Lipson Cancer and Blood Center
state: New York
city: Rochester
country: United States
facility: University of Rochester James P. Wilmot Cancer Center
state: New York
Study officials:
affiliation: University of Rochester
name: Joseph A Roscoe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: