Alternative Approaches for Nausea Control

Completed · Not applicable

Conditions studied: Nausea

In brief

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

Key facts

Study ID

NCT01695993

Run by

University of Rochester

People needed

242

Starts

2012-11-01

Expected to finish

2017-05-16

Last updated by the study team

2018-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
• Be receiving concurrent radiotherapy or interferon.

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• Hematology-Oncology Associates of Central New York — East Syracuse, New York, United States
• Rochester General Hospital's Lipson Cancer and Blood Center — Rochester, New York, United States
• University of Rochester James P. Wilmot Cancer Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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