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A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors


N/A
5 Years
35 Years
Not Enrolling
Both
Brain Tumors, Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Lymphoma, Nausea, Vomiting, Neuroblastoma, Ovarian Cancer, Sarcoma

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Trial Information

A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors


OBJECTIVES:

Primary

- Determine the efficacy of electroacupuncture, in terms of reducing acute and delayed
chemotherapy-induced nausea, in patients with newly diagnosed pediatric sarcoma,
neuroblastoma, nasopharyngeal carcinoma, or germ cell tumors.

Secondary

- Determine the efficacy of this therapy, in terms of reducing delayed
chemotherapy-induced emesis, in these patients.

- Determine the efficacy of this therapy, in terms of altering salivary cortisol levels
and fasting serum glucose and insulin levels as stress parameters, in these patients.

- Determine the efficacy of this therapy, in terms of improving the quality of life, in
these patients.

- Determine the efficacy of this therapy, in terms of reducing acute nausea and emesis,
in these patients.

OUTLINE: This is a multicenter, randomized, double-blind study. Patients are stratified
according to planned treatment with cisplatin-based chemotherapy (yes vs no) and gender.
Patients are randomized to 1 of 2 arms.

- Arm I: Patients undergo electroacupuncture to specific acupuncture points on the arms
and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7
during week 1 of chemotherapy course 1 (9 acupuncture treatments total).

- Arm II: Patients undergo electroacupuncture to sham points on the arms and legs as in
arm I.

Quality of life is assessed at baseline, on days 1 and 8 of each treatment course, and then
after completion of the study.

PROJECTED ACCRUAL: A total of 65 patients (approximately 32 per arm) will be accrued for
this study within 2.5-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed malignancy of 1 of the following types:

- Pediatric sarcoma

- Neuroblastoma

- Nasopharyngeal carcinoma

- Germ cell tumor

- Hodgkin lymphoma

- Meets 1 of the following criteria:

- Eligible for Children's Oncology Group (COG) protocol for sarcoma,
neuroblastoma, or germ cell tumor

- Eligible for NCI Pediatric Oncology Branch (POB) protocol for sarcoma

- Following COG-approved standard treatment regimen for sarcoma, neuroblastoma,
nasopharyngeal carcinoma, or germ cell tumor

- Enrolled on the POB natural history protocol 98-C-0037

- Planned treatment, according to COG or POB protocols, that includes a cisplatin-
and/or doxorubicin-containing regimen for sarcoma, neuroblastoma, nasopharyngeal
carcinoma, germ cell tumor, or Hodgkin lymphoma OR either a
cyclophosphamide/ifosfamide-doxorubicin-containing or
cyclophosphamide/dactinomycin-containing regimen for rhabdomyosarcoma

- No clinical or radiographic signs of spinal cord compression

PATIENT CHARACTERISTICS:

Age:

- 5 to 35

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count greater than 50,000/mm^3 (transfusion independent)

- No clotting disorders, including hemophilia

Hepatic:

- PT and PTT normal (within 10% of institution's upper limit of normal)

Renal:

- Not specified

Other:

- Not pregnant

- No casting of 1 or more extremities

- No other condition that would preclude access to acupuncture points

- No cognitive impairment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior systemic chemotherapy

Endocrine therapy:

- More than 4 weeks since prior glucocorticoid therapy

- No concurrent glucocorticoid therapy

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No prior acupuncture

- No concurrent anticoagulants

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Outcome Measure:

Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion

Outcome Description:

A two-sample t-test will be used. In the event the data are not normally distributed in one or both arms, a Wilcoxon rank sum test will be used.

Outcome Time Frame:

7 days

Safety Issue:

No

Principal Investigator

Kara Kelly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

ACCL04C2

NCT ID:

NCT00040911

Start Date:

April 2005

Completion Date:

January 2011

Related Keywords:

  • Brain Tumors
  • Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Head and Neck Cancer
  • Lymphoma
  • Nausea
  • Vomiting
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • nausea and vomiting
  • localized osteosarcoma
  • metastatic osteosarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • previously untreated childhood rhabdomyosarcoma
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • childhood teratoma
  • childhood extragonadal germ cell tumor
  • childhood malignant testicular germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood central nervous system germ cell tumor
  • localized resectable neuroblastoma
  • localized unresectable neuroblastoma
  • disseminated neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • stage I lymphoepithelioma of the nasopharynx
  • stage I squamous cell carcinoma of the nasopharynx
  • stage II lymphoepithelioma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage I adult Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • Brain Neoplasms
  • Head and Neck Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Nausea
  • Nervous System Neoplasms
  • Neuroblastoma
  • Ovarian Neoplasms
  • Vomiting
  • Central Nervous System Neoplasms
  • Nasopharyngeal Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182