Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma

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Brief Title

Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma

Official Title

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

Brief Summary

      RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in
      patients treated with chemotherapy.

      PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture
      in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly
      diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or
      Hodgkin lymphoma.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion

Condition

Brain Tumors

Intervention

electroacupuncture therapy

Study Arms / Comparison Groups

 Arm I (alternative medicine procedure)
Description:  Patients undergo electroacupuncture therapy 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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

17

Start Date

April 2005

Completion Date

January 2011

Primary Completion Date

October 2009

Eligibility 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
      

Gender

All

Ages

5 Years - 35 Years

Accepts Healthy Volunteers

No

Contacts

Kara Kelly, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00040911

Organization ID

ACCL04C2

Secondary IDs

NCCAM-02-AT-0172

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Kara Kelly, MD, Study Chair, Herbert Irving Comprehensive Cancer Center


Verification Date

May 2013