Solid TumorsNCT00487331
Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
A study testing Acupuncture and Survey in people with Solid Tumors and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if using acupuncture with or without electrical stimulation in cancer patients with high levels of pain can help to relieve the pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors, Pain
- What is being tested?
- Acupuncture and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients, or the legal guardians of patients must have the ability to understand English, sign a written informed consent, and be willing to follow protocol requirements.
- ECOG Performance Status of 0, 1, or 2.
- Pain score >/= 4 on the on a 0-10 NRS pain scale after all efforts have been attempted in the PMC to control pain.
Who cannot join
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- Deformities that could interfere with accurate acupuncture point location.
- Known coagulopathy and taking any dose of warfarin (i.e., Coumadin) or heparin, including low molecular weight heparin (i.e., Lovenox). Patients may participate if they are taking Plavix, aspirin or other non-steroidal anti-inflammatory agents.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry as these patients may not be able to cooperative with this slightly invasive procedure or with the data collection process.
- Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not lab work is drawn prior to beginning the acupuncture treatment will be left to the discretion of the referring physician. Patients with platelets <100,000 may participate with written approval from the attending physician.)
- Planned changes in the pain medication regimen.
- Women who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is to learn if using acupuncture with or without electrical stimulation in cancer patients with high levels of pain can help to relieve the pain.
Read the detailed description
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. The needles are placed in areas that are intended to help relieve pain. Electrical stimulation is often applied to the needles to improve the treatment effects. The procedure is designed to be comfortable and relaxing.
Acupuncture Sessions:
If you are found to be eligible to take part in this study, you will receive acupuncture sessions 1-3 times per week in the acupuncture clinic at M. D. Anderson. The number of sessions will depend on the type and location of the pain you may be experiencing.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body and/or ears where the needles will be placed. These points will be chosen based on the symptoms you are having at the time of treatment, the location of the pain, and the type of pain.
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin, the number of needles, and whether the needles are near or far from the areas of pain will vary from person to person, based on standard acupuncture procedures.
In most instances, needles placed on body points will remain in place for about 20-30 minutes. This length of time is the same for some points on the ears as well, but in some instances, small gold or stainless steel needles may be placed on the ears. These needles for the ears are designed to remain in place for 3-4 days. The ear needles are slightly larger than the head of a pin and have a small ridge that is designed to help them remain in place. If you prefer, a small flesh colored adhesive patch can be placed over the ear needles as added protection. This is usually not necessary, but can be added if you prefer.
Electrical stimulation may be added to some of the needles, depending on the type of pain you are experiencing and where it is located. This involves placing wires on the needles, which are connected to a machine that delivers a mild electrical current through the wires. The intensity (strength) of the electrical current will be adjusted gradually until it is at a comfortable level for you.
Study Procedures:
At each session, before you receive the acupuncture, the following procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any medications you may be taking and any side effects you may be experiencing.
- The color and coating of your tongue and the quality of your pulse will be recorded.
- If you are receiving medications that are known to affect your blood counts, blood (about 1 teaspoon) will be drawn for routine tests to check your blood counts.
Each study visit will last about 1 hour. During the study, you may still receive your regular pain treatments outside of this study.
Length of Study Participation:
You may receive up to 10 acupuncture sessions (depending on the location and type of pain). If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
On the day of your last acupuncture session (called the end-of-study visit), or if you go off study early for any reason, the following procedures will be performed:
Your medical history will be recorded. Your vital signs will be measured. You will be asked about any medications you may be taking and any side effects you may have experienced.
You will complete the same 2 pain questionnaires as before. You will also complete a questionnaire that has questions about your level of satisfaction with the acupuncture services that were provided. In total, the 3 questionnaires should take about 15 minutes to complete.
Your tongue and pulse will be evaluated.
Study Completion:
After the end-of-study visit, your participation in this study will be over.
This is an investigational study. The needles used in this study are FDA approved for use in patients with cancer. It is considered experimental, however, to provide acupuncture services to patients with cancer who have uncontrolled pain. Up to 64 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Solid Tumors, Pain
- Being tested
- Acupuncture, Survey
- Keywords
- Solid Tumors, Acupuncture, Uncontrolled Pain, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture sessions 1-3 times per week.
SurveyBehavioural
Also called questionnaire
2 pain questionnaires + satisfaction survey completed at beginning and end of treatment
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture sessions 1-3 times per week. 2 pain questionnaires + satisfaction survey completed at beginning and end of treatment. Receives: Other: Acupuncture; Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Reported Satisfaction with Acupuncture Services
Measured: Derived from surveys completed by participating patients over 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larry C. Driver, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487331
- Sponsor's protocol ID
- 2006-1113
- Status last verified
- Oct 2013
- First submitted
- 15 Jun 2007
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00487331
- Acronym / sponsor ID
- 2006-1113
- Conditions
- Solid Tumors, Pain
- Keywords
- Solid Tumors, Acupuncture, Uncontrolled Pain, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Jun 2007 (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 goal of this clinical research study is to learn if using acupuncture with or without electrical stimulation in cancer patients with high levels of pain can help to relieve the pain.
Detailed description
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. The needles are placed in areas that are intended to help relieve pain. Electrical stimulation is often applied to the needles to improve the treatment effects. The procedure is designed to be comfortable and relaxing.
Acupuncture Sessions:
If you are found to be eligible to take part in this study, you will receive acupuncture sessions 1-3 times per week in the acupuncture clinic at M. D. Anderson. The number of sessions will depend on the type and location of the pain you may be experiencing.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body and/or ears where the needles will be placed. These points will be chosen based on the symptoms you are having at the time of treatment, the location of the pain, and the type of pain.
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin, the number of needles, and whether the needles are near or far from the areas of pain will vary from person to person, based on standard acupuncture procedures.
In most instances, needles placed on body points will remain in place for about 20-30 minutes. This length of time is the same for some points on the ears as well, but in some instances, small gold or stainless steel needles may be placed on the ears. These needles for the ears are designed to remain in place for 3-4 days. The ear needles are slightly larger than the head of a pin and have a small ridge that is designed to help them remain in place. If you prefer, a small flesh colored adhesive patch can be placed over the ear needles as added protection. This is usually not necessary, but can be added if you prefer.
Electrical stimulation may be added to some of the needles, depending on the type of pain you are experiencing and where it is located. This involves placing wires on the needles, which are connected to a machine that delivers a mild electrical current through the wires. The intensity (strength) of the electrical current will be adjusted gradually until it is at a comfortable level for you.
Study Procedures:
At each session, before you receive the acupuncture, the following procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any medications you may be taking and any side effects you may be experiencing.
- The color and coating of your tongue and the quality of your pulse will be recorded.
- If you are receiving medications that are known to affect your blood counts, blood (about 1 teaspoon) will be drawn for routine tests to check your blood counts.
Each study visit will last about 1 hour. During the study, you may still receive your regular pain treatments outside of this study.
Length of Study Participation:
You may receive up to 10 acupuncture sessions (depending on the location and type of pain). If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
On the day of your last acupuncture session (called the end-of-study visit), or if you go off study early for any reason, the following procedures will be performed:
Your medical history will be recorded. Your vital signs will be measured. You will be asked about any medications you may be taking and any side effects you may have experienced.
You will complete the same 2 pain questionnaires as before. You will also complete a questionnaire that has questions about your level of satisfaction with the acupuncture services that were provided. In total, the 3 questionnaires should take about 15 minutes to complete.
Your tongue and pulse will be evaluated.
Study Completion:
After the end-of-study visit, your participation in this study will be over.
This is an investigational study. The needles used in this study are FDA approved for use in patients with cancer. It is considered experimental, however, to provide acupuncture services to patients with cancer who have uncontrolled pain. Up to 64 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture, Behavioral: SurveyAcupuncture sessions 1-3 times per week. 2 pain questionnaires + satisfaction survey completed at beginning and end of treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients, or the legal guardians of patients must have the ability to understand English, sign a written informed consent, and be willing to follow protocol requirements.
- ECOG Performance Status of 0, 1, or 2.
- Pain score >/= 4 on the on a 0-10 NRS pain scale after all efforts have been attempted in the PMC to control pain.
Key exclusion criteria (7 listed)
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- Deformities that could interfere with accurate acupuncture point location.
- Known coagulopathy and taking any dose of warfarin (i.e., Coumadin) or heparin, including low molecular weight heparin (i.e., Lovenox). Patients may participate if they are taking Plavix, aspirin or other non-steroidal anti-inflammatory agents.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry as these patients may not be able to cooperative with this slightly invasive procedure or with the data collection process.
- Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not lab work is drawn prior to beginning the acupuncture treatment will be left to the discretion of the referring physician. Patients with platelets <100,000 may participate with written approval from the attending physician.)
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 sessions 1-3 times per week. | Other | Acupuncture |
| SurveyAlso: questionnaire2 pain questionnaires + satisfaction survey completed at beginning and end of treatment | Behavioural | Acupuncture |
Primary outcome
Patients' Reported Satisfaction with Acupuncture Services
Time frame: Derived from surveys completed by participating patients over 3 Years
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 9 Jan 2015.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Larry C. Driver, MD principal investigator
M.D. Anderson 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 Acupuncture and Survey in people with Solid Tumors and Pain, run by M.D. Anderson 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 3 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 9 Jan 2015. 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.
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?
Patients' Reported Satisfaction with Acupuncture Services (time frame: Derived from surveys completed by participating patients over 3 Years). 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 9 Jan 2015.