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

NCT00040911 | Completed DMC

• 5 other identifiers: ACCL04C2NCCAM-02-AT-0172NCI-02-AT-0172COG-ACCL04C2CDR0000069419
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  7 days

Secondary Outcomes (2)

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

  Day 8

• Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion

  Day 1

Study Arms (2)

Arm I (alternative medicine procedure)

EXPERIMENTAL

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).

Procedure: electroacupuncture therapy; Procedure: quality-of-life assessment

Arm II (alternative medicine procedure)

SHAM COMPARATOR

Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.

Procedure: sham intervention; Procedure: quality-of-life assessment

Interventions

electroacupuncture therapy PROCEDURE

Arm I (alternative medicine procedure)

sham intervention PROCEDURE

Undergo electroacupuncture therapy to sham points

Arm II (alternative medicine procedure)

quality-of-life assessment PROCEDURE

Ancillary studies

Arm I (alternative medicine procedure); Arm II (alternative medicine procedure)

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms; Head and Neck Neoplasms; Lymphoma; Nausea; Vomiting; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Osteosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Teratoma; Testicular Neoplasms; Ovarian Germ Cell Cancer; Hodgkin Disease

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

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

• Kara Kelly, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2011
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (1)