Pancreatic NeoplasmsPhase 3NCT00136669
Acupuncture For Pancreatic Cancer Pain
A Phase 3 study testing Acupuncture in people with Pancreatic Neoplasms and Pain, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are conducting a Phase III study to determine the effects of acupuncture on pain in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2005
- Phase
- Phase 3
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of pancreatic adenocarcinoma.
- First baseline current pain score of 3 or above on a 0 - 10 numerical rating scale.
- In the opinion of the treating physician or a medically qualified investigator, the patient's pain syndrome is the result of underlying cancer.
- Patient OR caregiver must be willing and able to apply pressure to each point using small circular movements with the fingers twice per day.
Who cannot join
- Primary cause of pain is procedural (e.g. postoperative pain).
- Acupuncture treatment in the past six weeks. Patients should not receive acupuncture during the one week period of the study.
- Neutropenia defined as absolute neutrophil count (ANC) <1000/microliter.
- Cardiac conditions constituting high or moderate risk of endocarditis as defined by the American Heart Association criteria.
- Patient contraindicated for phlebotomy, as phlebotomy needles are much larger than acupuncture needles.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study
Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are conducting a Phase III study to determine the effects of acupuncture on pain in patients with pancreatic cancer. The purpose of a Phase III study is to determine whether or not a treatment is helpful. This study will include about 60 patients.
Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent years, researchers have found evidence that acupuncture is useful in treating a variety of conditions, including headache, nausea, and pain.
Read the detailed description
The main aim of this pancreatic cancer pain trial is to determine the effects of a single, practitioner-given acupuncture treatment followed by semi-permanent acupuncture studs. Our primary endpoint is subjective; therefore, a placebo control will be applied with patients blinded to treatment allocation.
In clinical practice, acupuncturists individualize treatment: two patients with a similar conventional diagnosis may receive different point prescriptions depending on the acupuncture differential diagnosis. Randomized trials of acupuncture can either prescribe a fixed treatment formula in terms of the number of sessions and points to be used, or allow practitioners to exercise clinical judgment in individualizing care. There has been considerable debate in the methodological literature about the merits of each approach. The use of a fixed treatment schedule increases the reproducibility of the findings but is said, by practitioners, to generally reduce treatment effectiveness. In this trial, we have developed an approach that allows practitioners to individualize treatments in a manner that allows exact replication, by specifying particular point locations to be used depending on the sites where a patient experiences pain. Point locations for this and for all of our acupuncture studies are determined by our licensed, credentialled acupuncturists.
Following accrual of the initial 10-15 patients, we will review treatment compliance, blinding and accrual. Adjustments will be made to deal with compliance issues, to facilitate placebo blinding, or deal with recruitment problems for the remainder of the study.
- Conditions
- Pancreatic Neoplasms, Pain
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Pain, Pancreatic Neoplasms
- Medical subject headings
- Pancreatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo
To determine the duration of acupuncture effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Barrie R. Cassileth, Ph.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136669
- Sponsor's protocol ID
- 03-106
- Status last verified
- Sep 2006
- First submitted
- 25 Aug 2005
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT00136669
- Acronym / sponsor ID
- 03-106
- Conditions
- Pancreatic Neoplasms, Pain
- Keywords
- Acupuncture, Pain, Pancreatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Sep 2005
- First posted
- 29 Aug 2005 (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.
Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are conducting a Phase III study to determine the effects of acupuncture on pain in patients with pancreatic cancer. The purpose of a Phase III study is to determine whether or not a treatment is helpful. This study will include about 60 patients.
Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent years, researchers have found evidence that acupuncture is useful in treating a variety of conditions, including headache, nausea, and pain.
Detailed description
The main aim of this pancreatic cancer pain trial is to determine the effects of a single, practitioner-given acupuncture treatment followed by semi-permanent acupuncture studs. Our primary endpoint is subjective; therefore, a placebo control will be applied with patients blinded to treatment allocation.
In clinical practice, acupuncturists individualize treatment: two patients with a similar conventional diagnosis may receive different point prescriptions depending on the acupuncture differential diagnosis. Randomized trials of acupuncture can either prescribe a fixed treatment formula in terms of the number of sessions and points to be used, or allow practitioners to exercise clinical judgment in individualizing care. There has been considerable debate in the methodological literature about the merits of each approach. The use of a fixed treatment schedule increases the reproducibility of the findings but is said, by practitioners, to generally reduce treatment effectiveness. In this trial, we have developed an approach that allows practitioners to individualize treatments in a manner that allows exact replication, by specifying particular point locations to be used depending on the sites where a patient experiences pain. Point locations for this and for all of our acupuncture studies are determined by our licensed, credentialled acupuncturists.
Following accrual of the initial 10-15 patients, we will review treatment compliance, blinding and accrual. Adjustments will be made to deal with compliance issues, to facilitate placebo blinding, or deal with recruitment problems for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of pancreatic adenocarcinoma.
- First baseline current pain score of 3 or above on a 0 - 10 numerical rating scale.
- In the opinion of the treating physician or a medically qualified investigator, the patient's pain syndrome is the result of underlying cancer.
- Patient OR caregiver must be willing and able to apply pressure to each point using small circular movements with the fingers twice per day.
Key exclusion criteria (5 listed)
- Primary cause of pain is procedural (e.g. postoperative pain).
- Acupuncture treatment in the past six weeks. Patients should not receive acupuncture during the one week period of the study.
- Neutropenia defined as absolute neutrophil count (ANC) <1000/microliter.
- Cardiac conditions constituting high or moderate risk of endocarditis as defined by the American Heart Association criteria.
- Patient contraindicated for phlebotomy, as phlebotomy needles are much larger than acupuncture needles.
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo
To determine the duration of acupuncture effects
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 8 Sep 2006.
- (Memorial Sloan-Kettering Cancer Center)Link 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.
Barrie R. Cassileth, Ph.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Pancreatic Neoplasms and Pain, run by Memorial Sloan Kettering Cancer Center 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 4 inclusion and 5 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 8 Sep 2006. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo. 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 8 Sep 2006.