Status:
WITHDRAWN
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Acute Lymphoblastic Leukemia
Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the insi...
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea ...
Eligibility Criteria
Inclusion
- Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.
- Planned to undergo at least 2 more cycles of chemotherapy.
- Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma
- History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.
- Age 8-21.
- Parent must be able to understand and willing to sign written informed consent document.
Exclusion
- Prior knowledge of acupuncture or experience with acupuncture or acupressure.
- There will be no restrictions regarding use of other Investigational Agents.
- Comorbid Diseases:
- Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement).
- Any diagnosis requiring pediatric intensive care unit admission.
- Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results)
- Concomitant radiation therapy during current chemotherapy cycle.
- Developmental delay patients with allergy to tape or leads will be excluded from the study.
- Pregnant patients will be excluded from the study.
- Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy.
- HIV-positive patients will not be excluded.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01492569
Start Date
May 1 2012
Last Update
June 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305