Alternative Approaches for Nausea Control

University of Rochester

Status: Completed

Conditions: Nausea

Treatments: Behavioral: Expectancy-enhancing MP3; Other: Expectancy-neutral handout; Other: Expectancy-enhancing handout; Behavioral: Expectancy-neutral MP3; Device: Acupressure bands

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01695993

UCCS1202

R01AT007474-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 242 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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242 participants in 3 patient groups

Arm 1 - Standard Care Only

No Intervention group

Description:

Patients will receive standard care only

Arm 2 - Expectancy-neutral Arm

Other group

Description:

Patients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands

Treatment:

Other: Expectancy-neutral handout

Device: Acupressure bands

Behavioral: Expectancy-neutral MP3

Arm 3 - Expectancy-enhancing Arm

Experimental group

Description:

Patients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands

Treatment:

Other: Expectancy-enhancing handout

Device: Acupressure bands

Behavioral: Expectancy-enhancing MP3