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Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer Clinical research trials and Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer  Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
For Condition: Breast Cancer,nausea and vomiting
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known if acupressure plus standard care for nausea is more effective than standard care for nausea alone in women who are receiving chemotherapy for breast cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.
Details: 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 and third courses 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SuzanneDibble, Principal Investigator, M.D. Anderson Cancer Center
University of Texas M.D. Anderson CCOP Research Base *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Sandra Sinclair 713-792-8515
H. Lee Moffitt Cancer Center CCOP Research Base *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Viki Huegel 813-903-7193
Additional Information:
Study ID Numbers: CDR0000257016; MDA-NUR01-396,NCI-P02-0230,NCI-0109
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046865
Other Breast Cancer Studies:
1. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
2. Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
3. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
4. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
5. Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Related Studies:
Other Breast Cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
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