NCT00046865

Brief Summary

RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2006

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.7 years

First QC Date

October 3, 2002

Last Update Submit

November 12, 2018

Conditions

Breast CancerDrug-induced Nausea and Vomiting

Keywords

nausea and vomitingstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Study Arms (3)

Acupressure

EXPERIMENTAL

Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.

Procedure: acupressure therapyProcedure: management of therapy complicationsProcedure: nausea and vomiting therapy

Placebo Acupressure

PLACEBO COMPARATOR

Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.

Procedure: acupressure therapyProcedure: management of therapy complicationsProcedure: nausea and vomiting therapy

Usual Care

SHAM COMPARATOR

Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

Procedure: management of therapy complicationsProcedure: nausea and vomiting therapy

Interventions

acupressure therapyPROCEDURE
AcupressurePlacebo Acupressure
management of therapy complicationsPROCEDURE
AcupressurePlacebo AcupressureUsual Care
nausea and vomiting therapyPROCEDURE
AcupressurePlacebo AcupressureUsual Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer and receiving one of the following combination therapy regimens: * Doxorubicin and cyclophosphamide with or without fluorouracil * Doxorubicin with paclitaxel or docetaxel * Fluorouracil, epirubicin, and cyclophosphamide * Must be beginning second or third course of chemotherapy * Nausea intensity with prior chemotherapy of at least 3 (moderate) on the intensity scale of the Morrow Assessment of Nausea and Emesis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Adult Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Concurrent antiemetics allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

H. Lee Moffitt Cancer Center CCOP Research Base

Tampa, Florida, 33612, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsVomitingNausea

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Suzanne L. Dibble, DNSc, RN, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

March 23, 2006

Study Completion

March 23, 2006

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(2)