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Alternative Approaches for Nausea Control

24. maj 2018 opdateret af: Joseph Roscoe, University of Rochester

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

242

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Forenede Stater, 13057
        • Hematology-Oncology Associates of Central New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester James P. Wilmot Cancer Center
      • Rochester, New York, Forenede Stater, 14621
        • Rochester General Hospital's Lipson Cancer and Blood Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Arm 1 - Standard Care Only
Patients will receive standard care only
Andet: Arm 2 - Expectancy-neutral Arm

Patients receive:

  1. Expectancy-neutral handout
  2. Expectancy-neutral MP3
  3. Acupressure bands
Enhed: Acupressure bands
Bilateral acupressure wrist bands
Andet: Expectancy-neutral handout
The expectancy neutral handout has neutral information regarding the acupressure bands
Adfærdsmæssigt: Expectancy-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.
Eksperimentel: Arm 3 - Expectancy-enhancing Arm

Patients receive:

  1. Expectancy-enhancing handout
  2. Expectancy-enhancing MP3
  3. Acupressure bands
Enhed: Acupressure bands
Bilateral acupressure wrist bands
Andet: Expectancy-enhancing handout
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
Adfærdsmæssigt: Expectancy-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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Report Nausea Diary
Tidsramme: 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.
five days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Rochester

Samarbejdspartnere

National Center for Complementary and Integrative Health (NCCIH)

Efterforskere

  • Ledende efterforsker: Joseph A Roscoe, Ph.D., University of Rochester

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2012

Primær færdiggørelse (Faktiske)

16. maj 2017

Studieafslutning (Faktiske)

16. maj 2017

Datoer for studieregistrering

Først indsendt

26. september 2012

Først indsendt, der opfyldte QC-kriterier

26. september 2012

Først opslået (Skøn)

28. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCCS1202
  • R01AT007474-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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