Childhood Acute Lymphoblastic LeukemiaNCT01492569
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
A study testing electroacupuncture therapy and questionnaire administration in people with Childhood Acute Lymphoblastic Leukemia and Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma
- What is being tested?
- electroacupuncture therapy and questionnaire administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2013
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: 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.
ARM II: 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.
- Conditions
- Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma, Vomiting in Infants and/or Children, Osteosarcoma
- Being tested
- electroacupuncture therapy, questionnaire administration
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sarcoma, Ewing, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture therapyProcedure or surgery
Also called electroacupuncture
Undergo TAPS at sham point
questionnaire administrationOther
Ancillary studies
electroacupuncture therapyProcedure or surgery
Also called electroacupuncture
Undergo TAPS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: electroacupuncture therapy; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of vomiting
Measured: 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.
Measured: During the first 24 hours of chemotherapy
Secondary outcomes (1)
Number of as needed (PRN) antiemetic medications needed
Measured: After the first 24 hours of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionJul 2013 (estimated)
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brenda Golianu, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492569
- Sponsor's protocol ID
- PEDSVAR0016
- Other IDs
- NCI-2011-03653
- Status last verified
- Jun 2013
- First submitted
- 13 Dec 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01492569
- Acronym / sponsor ID
- PEDSVAR0016
- Conditions
- Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma, Vomiting in Infants and/or Children, Osteosarcoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- Jul 2013 (estimated)
- First posted
- 15 Dec 2011 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: 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.
ARM II: 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (TAPS at the P6 point) | Experimental | Other: questionnaire administration, Procedure: electroacupuncture therapyPatients 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. |
| Arm II (TAPS at a non-P6 point) | Sham comparator | Procedure: electroacupuncture therapy, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Prior knowledge of acupuncture or experience with acupuncture or acupressure.
- There will be no restrictions regarding use of other Investigational Agents.
- Comorbid Diseases:
- 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.
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 therapyAlso: electroacupunctureUndergo TAPS at sham point | Procedure or surgery | Arm II (TAPS at a non-P6 point) |
| questionnaire administrationAncillary studies | Other | Arm I (TAPS at the P6 point), Arm II (TAPS at a non-P6 point) |
| electroacupuncture therapyAlso: electroacupunctureUndergo TAPS | Procedure or surgery | Arm I (TAPS at the P6 point) |
Primary outcome
Number of episodes of vomiting
Time frame: During the first 24 hours of chemotherapy
Severity of nausea as recorded on the visual analogue scale (VAS)
Time frame: During the first 24 hours of chemotherapy
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.
1 secondary outcome
Number of as needed (PRN) antiemetic medications needed
Time frame: After the first 24 hours of chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Brenda Golianu principal investigator
Stanford University
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 questionnaire administration in people with Childhood Acute Lymphoblastic Leukemia and Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, run by Stanford University 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?
The sponsor lists 6 inclusion and 11 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 12 Jun 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of episodes of vomiting (time frame: During the first 24 hours of chemotherapy). The study lists 2 primary outcomes in all. 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 12 Jun 2013.