Brain TumorsNCT00040911
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
A study testing electroacupuncture therapy and quality-of-life assessment in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Brain Tumors, Central Nervous System Tumors, Childhood Germ Cell Tumor
- What is being tested?
- electroacupuncture therapy and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
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.
Read the 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.
- Conditions
- Brain Tumors, Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Lymphoma
- Being tested
- electroacupuncture therapy, sham intervention, quality-of-life assessment
- 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
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms, Head and Neck Neoplasms, Lymphoma, Nausea, Vomiting, Neuroblastoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture therapyProcedure or surgery
sham interventionProcedure or surgery
Undergo electroacupuncture therapy to sham points
quality-of-life assessmentProcedure or surgery
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: sham intervention; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Measured: Day 8
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2005
- Primary completionOct 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Kara Kelly, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040911
- Sponsor's protocol ID
- ACCL04C2
- Other IDs
- NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2, CDR0000069419
- Status last verified
- May 2013
- First submitted
- 8 Jul 2002
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
- ClinicalTrials.gov ID
- NCT00040911
- Acronym / sponsor ID
- ACCL04C2
- Conditions
- Brain Tumors, Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Lymphoma
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (alternative medicine procedure) | Experimental | Procedure: electroacupuncture therapy, Procedure: quality-of-life assessmentPatients 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). |
| Arm II (alternative medicine procedure) | Sham comparator | Procedure: sham intervention, Procedure: quality-of-life assessmentPatients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I. |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncture therapy | Procedure or surgery | Arm I (alternative medicine procedure) |
| sham interventionUndergo electroacupuncture therapy to sham points | Procedure or surgery | Arm II (alternative medicine procedure) |
| quality-of-life assessmentAncillary studies | Procedure or surgery | Arm I (alternative medicine procedure), Arm II (alternative medicine procedure) |
Primary outcome
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
Time frame: 7 days
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.
2 secondary outcomes
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Time frame: Day 8
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Kelly, MD study chair
Herbert Irving Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture therapy and quality-of-life assessment in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.