Clinical trial NCT01492569: Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Official title: Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Acute Lymphoblastic Leukemia
Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Ewing Sarcoma
Vomiting in Infants and/or Children
Osteosarcoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 inside of the wrist may help control nausea and vomiting during chemotherapy.

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 and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.

ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of episodes of vomiting
timeFrame: During the first 24 hours of chemotherapy
measure: Severity of nausea as recorded on the visual analogue scale (VAS)
timeFrame: During the first 24 hours of chemotherapy
Secondary outcomes:
measure: Number of as needed (PRN) antiemetic medications needed
timeFrame: After the first 24 hours of chemotherapy
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Brenda Golianu
role: PRINCIPAL_INVESTIGATOR
References: