CancerNCT00401063
Usefulness of Acupuncture in Cancer Pain and Quality of Life
A study testing Acupuncture in people with Cancer and Pain, run by Southern California University of Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Oct 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of cancer by an MD/oncologist
- Age of 18 or older
- Baseline pain score of 3 or above on 0-10 rating scale
- In the evaluation of the treating physician or medically-qualified investigator, the patient's pain syndrome is the result of underlying cancer or cancer treatment
- Being ambulatory
- Permission from the treating physician (MD/oncologist)
- Platelet count of 50,000 or greater
Who cannot join
- Acupuncture treatment in past four weeks
- Neutropenia defined as ANC (absolute neutrophil count) < 1000/ml
- Inability to obtain permission from the treating physician
- Unwillingness to sign informed consent form
- Involvement in litigation
- Simultaneous infection with HIV or Hepatitis C virus
- Unable to present for follow up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Health Center
Pasadena, California, 91104
Southern California University of Health Sciences
Whittier, California, 90604
About this study
Official title: Acupuncture Case Series: Cancer Pain and Quality of Life
The purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite.
Read the detailed description
After receiving permission from the attending physician each study participant who meets the inclusion criteria will then undergo a physical examination and fill out several questionnaires. Each participant will undergo one to three treatments per week for a period of eight weeks. There will be one follow-up visit on the twelfth week. Participation in this study is free of charge, including all exams, treatment and informational material.
- Being tested
- Acupuncture
- Keywords
- Cancer, Acupuncture, Cancer Pain, Quality of life
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture treatment twice a day for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Acupuncture treatment Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
Measured: Every two weeks, 0, 2, 4, 6, 8 and 12
Visual Analogue Scale
Measured: Every two weeks, 0,2,4,6,8, and 12 weeks
Secondary outcomes (1)
BDI Psychological Assessment
Measured: Every two weeks, 0, 2, 4, 6, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sivarama Vinjamury, Southern California University of Health Sciences
- Investigators
- Sivarama P Vinjamury, MD, MAOM, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401063
- Sponsor's protocol ID
- SCU-06-VINJ001
- Status last verified
- May 2013
- First submitted
- 15 Nov 2006
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Case Series: Cancer Pain and Quality of Life
- ClinicalTrials.gov ID
- NCT00401063
- Acronym / sponsor ID
- SCU-06-VINJ001
- Keywords
- Cancer, Acupuncture, Cancer Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Nov 2006 (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.
The purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite.
Detailed description
After receiving permission from the attending physician each study participant who meets the inclusion criteria will then undergo a physical examination and fill out several questionnaires. Each participant will undergo one to three treatments per week for a period of eight weeks. There will be one follow-up visit on the twelfth week. Participation in this study is free of charge, including all exams, treatment and informational material.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: AcupunctureAcupuncture treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of cancer by an MD/oncologist
- Age of 18 or older
- Baseline pain score of 3 or above on 0-10 rating scale
- In the evaluation of the treating physician or medically-qualified investigator, the patient's pain syndrome is the result of underlying cancer or cancer treatment
- Being ambulatory
Key exclusion criteria (7 listed)
- Acupuncture treatment in past four weeks
- Neutropenia defined as ANC (absolute neutrophil count) < 1000/ml
- Inability to obtain permission from the treating physician
- Unwillingness to sign informed consent form
- Involvement in litigation
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 |
|---|---|---|
| AcupunctureAcupuncture treatment twice a day for eight weeks | Device | Single arm |
Primary outcome
EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
Time frame: Every two weeks, 0, 2, 4, 6, 8 and 12
Visual Analogue Scale
Time frame: Every two weeks, 0,2,4,6,8, and 12 weeks
1 secondary outcome
BDI Psychological Assessment
Time frame: Every two weeks, 0, 2, 4, 6, 8 and 12 weeks
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 30 May 2013.
- Visit Southern California University of Health Sciences WebsiteLink provided by the sponsor.
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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.
Sivarama P Vinjamury, MD, MAOM principal investigator
Southern California University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cancer and Pain, run by Southern California University of Health Sciences at 2 sites 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 30 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 2 sites 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. 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?
EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients (time frame: Every two weeks, 0, 2, 4, 6, 8 and 12). 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 30 May 2013.