Breast CancerPhase 3NCT00046865
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
A Phase 3 study testing acupressure therapy, management of therapy complications and nausea and vomiting therapy in people with Breast Cancer and Drug-induced Nausea and Vomiting, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Drug-induced Nausea and Vomiting
- What is being tested?
- acupressure therapy, management of therapy complications and nausea and vomiting therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2002to 23 Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa, Florida, 33612
About this study
Official title: Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
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.
Read the detailed description
OBJECTIVES:
- Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
- Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.
- 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.
- 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.
- Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer, Drug-induced Nausea and Vomiting
- Being tested
- acupressure therapy, management of therapy complications, nausea and vomiting therapy
- Keywords
- nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure therapyProcedure or surgery
management of therapy complicationsProcedure or surgery
nausea and vomiting therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: acupressure therapy; Procedure: management of therapy complications; Procedure: 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. Receives: Procedure: acupressure therapy; Procedure: management of therapy complications; Procedure: nausea and vomiting therapy |
| Usual Care | Sham comparator | Arm III: Patients receive usual nausea care during the second or third course of chemotherapy. Receives: Procedure: management of therapy complications; Procedure: nausea and vomiting therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start1 Jul 2002
- Primary completion23 Mar 2006
- Study completion23 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne L. Dibble, DNSc, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046865
- Sponsor's protocol ID
- CDR0000257016
- Other IDs
- MDA-NUR01-396, NCI-0109, NCI-P02-0230, NCI-5950, NUR01-396
- Status last verified
- Nov 2018
- First submitted
- 3 Oct 2002
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
- ClinicalTrials.gov ID
- NCT00046865
- Acronym / sponsor ID
- CDR0000257016
- Conditions
- Breast Cancer, Drug-induced Nausea and Vomiting
- Keywords
- nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2002 (actual)
- Primary completion
- 23 Mar 2006 (actual)
- Study completion
- 23 Mar 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
- Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.
- 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.
- 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.
- Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Procedure: acupressure therapy, Procedure: management of therapy complications, Procedure: nausea and vomiting therapyArm 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. |
| Placebo Acupressure | Placebo comparator | Procedure: acupressure therapy, Procedure: management of therapy complications, Procedure: nausea and vomiting therapyArm 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. |
| Usual Care | Sham comparator | Procedure: management of therapy complications, Procedure: nausea and vomiting therapyArm III: Patients receive usual nausea care during the second or third course of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure therapy | Procedure or surgery | Acupressure, Placebo Acupressure |
| management of therapy complications | Procedure or surgery | Acupressure, Placebo Acupressure, Usual Care |
| nausea and vomiting therapy | Procedure or surgery | Acupressure, Placebo Acupressure, Usual Care |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne L. Dibble, DNSc, RN, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupressure therapy, management of therapy complications and nausea and vomiting therapy in people with Breast Cancer and Drug-induced Nausea and Vomiting, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.