Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

NCT01492569 | Withdrawn DMC

• 2 other identifiers: PEDSVAR0016NCI-2011-03653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies; Ewing Sarcoma; Vomiting in Infants and/or Children; Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Number of episodes of vomiting

  During the first 24 hours of chemotherapy

• Severity of nausea as recorded on the visual analogue scale (VAS)

  Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool.

  During the first 24 hours of chemotherapy

Secondary Outcomes (1)

• Number of as needed (PRN) antiemetic medications needed

  After the first 24 hours of chemotherapy

Study Arms (2)

Arm I (TAPS at the P6 point)

EXPERIMENTAL

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.

Other: questionnaire administration; Procedure: electroacupuncture therapy

Arm II (TAPS at a non-P6 point)

SHAM COMPARATOR

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.

Procedure: electroacupuncture therapy; Other: questionnaire administration

Interventions

electroacupuncture therapy PROCEDURE

Undergo TAPS at sham point

Also known as: electroacupuncture

Arm II (TAPS at a non-P6 point)

questionnaire administration OTHER

Ancillary studies

Arm I (TAPS at the P6 point); Arm II (TAPS at a non-P6 point)

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sarcoma, Ewing; Osteosarcoma

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Brenda Golianu

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

US (1)