MucositisNCT00549835
Acupuncture for Mucositis Pain in Cancer Care
A study testing Real Acupuncture in people with Mucositis and Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Real Acupuncture
- Type of treatment
- 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
- Aug 2007to Oct 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with leukemia (such as acute myelogenous leukemia) and receiving chemotherapy for induction, consolidation or re-induction or high dose preparative regimen for bone marrow transplantation in the Johns Hopkins Oncology Inpatient Services
- Participation in standard leukemia-treatment regimens
- Expectation of survival of three weeks for completion of the study
Who cannot join
- Acupuncture treatment within the previous 6 weeks
- Unable to achieve platelet count of at least 10,000 with platelet support
- Radiation therapy within one month of enrollment
- Pregnant women
- History of substance abuse, including alcohol and IV drug users
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland
About this study
This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a frequent complication in cancer care and extremely painful, but also increases the risks of infection and malnutrition and often leads to discontinuing or delaying the chemotherapy treatments.
Read the detailed description
Acupuncture is one of the oldest, most commonly used medical procedures in the world. The practice originated in China more than 2,000 years ago, and is widely used by doctors in Korea, China, Japan, and other countries to ease pain or various symptoms. In the past two decades, acupuncture has grown in popularity in the United States, and by 2002, an estimated 8.2 million adults in the US report having used acupuncture.
The term acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation. Acupuncture needles are metallic, solid, and hair-thin. People experience acupuncture differently, but most feel no or minimal pain as the needles are inserted. Some people are energized by treatment, while others feel relaxed.
Acupuncture has been used to ease some cancer treatment-related side effects such as nausea and vomiting. In this study we will assess the potential usefulness of acupuncture to ease the pain associated with mucositis.
- Being tested
- Real Acupuncture, Sham Acupuncture
- Keywords
- mucositis pain, cancer, pain, acupuncture, mucositis, cancer pain
- Medical subject headings
- Mucositis, Pain, Leukemia, Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real AcupunctureProcedure or surgery
Sham AcupunctureProcedure or surgery
Sham needles are developed to exclude sham effect and to prove real acupuncture efficacy. We will use specifically retractable Park Sham Device (AcuPrime, Exeter, UK) for control group. Because this sham device gives the impression of insertion with telescopic needle body and some pricking sensation with a bunt needle tip. It is a valid control for many acupuncture trials as it doesn't penetrate skin and doesn't create active stimulation as much as real needles or acupressure. To avoid unnecessary stimulation of penetrating skin in this population, we plan to use non-penetrating sham device rather than penetrating non-acupuncture point with real needles as control intervention.
All other procedures will be same as Real Acupuncture group except using non-penetrating sham needles on non-acupuncture points. After final session, we will ask all subjects in both groups which form of treatment each subject believe to have during study and will analyze blinding credibility.
| Study group | Role | What they receive |
|---|---|---|
| Real Acupuncture | Active comparator | Participants will have acupuncture performed at a rate of 3 times (Mon, Wed, Fri) / week for total of 2 weeks (total of 6 sessions). We will follow Saam Acupuncture methods, which have been the mainstream of acupuncture methodology in most Korean Oriental Medical Colleges and among clinical practitioners >400 years. Standardized acupuncture prescriptions for mucositis will be acupuncture points tonifying Spleen Meridian (R side) and Small Intestine Meridian (L side). In Oriental Medicine, the spleen has functions of promoting water metabolism, transporting nutrients, and controlling blood. Mouth belongs to the spleen system according to Five element theory. Small intestine is related with mucositis symptoms including thirst and tongue ulcers. We will use sterile, disposable, filiform needles, size 0.16 (40Gauge) - 0.30 mm (30Gauge) in diameter and 15-40 mm long. Total number of acupuncture needles will be 8 (4 needles each side) and needles will be retained for 20 minutes. Receives: Procedure: Real Acupuncture; Procedure: Sham Acupuncture |
| Sham Acupuncture | Sham comparator | Newly diagnosed leukemia patients will be recruited from the large patient population on the Leukemia Inpatient Services who will be receiving high dose preperative regimens such as Busulfan + Cytarabine for marrow transplantation. Receives: Procedure: Real Acupuncture; Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Retention/ dropout rate
Measured: 12 weeks
Sham credibility rate
Measured: 12 weeks
Frequency of any adverse effects
Bleeding, infection, bruising, etc
Measured: 12 weeks
Secondary outcomes (3)
Pain levels
Measured: 12 weeks
Mucositis Grade
CTC Scoring, Hopkins Scoring; Oral Mucositis Daily Questionnaire (OMDQ)
Measured: 12 weeks
Total amount of conventional analgesics used and Total days on Analgesic
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Adrian S Dobs, MD MHS, Principal investigator, Johns Hopkins UniversitySanghoon Lee, KMD PhD LAc, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549835
- Sponsor's protocol ID
- NA_00008179
- Status last verified
- Mar 2015
- First submitted
- 24 Oct 2007
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Mucositis Pain in Cancer Care
- ClinicalTrials.gov ID
- NCT00549835
- Acronym / sponsor ID
- NA_00008179
- Keywords
- mucositis pain, cancer, pain, acupuncture, mucositis, cancer pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Oct 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.
This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a frequent complication in cancer care and extremely painful, but also increases the risks of infection and malnutrition and often leads to discontinuing or delaying the chemotherapy treatments.
Detailed description
Acupuncture is one of the oldest, most commonly used medical procedures in the world. The practice originated in China more than 2,000 years ago, and is widely used by doctors in Korea, China, Japan, and other countries to ease pain or various symptoms. In the past two decades, acupuncture has grown in popularity in the United States, and by 2002, an estimated 8.2 million adults in the US report having used acupuncture.
The term acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation. Acupuncture needles are metallic, solid, and hair-thin. People experience acupuncture differently, but most feel no or minimal pain as the needles are inserted. Some people are energized by treatment, while others feel relaxed.
Acupuncture has been used to ease some cancer treatment-related side effects such as nausea and vomiting. In this study we will assess the potential usefulness of acupuncture to ease the pain associated with mucositis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Acupuncture | Active comparator | Procedure: Real Acupuncture, Procedure: Sham AcupunctureParticipants will have acupuncture performed at a rate of 3 times (Mon, Wed, Fri) / week for total of 2 weeks (total of 6 sessions). We will follow Saam Acupuncture methods, which have been the mainstream of acupuncture methodology in most Korean Oriental Medical Colleges and among clinical practitioners >400 years. Standardized acupuncture prescriptions for mucositis will be acupuncture points tonifying Spleen Meridian (R side) and Small Intestine Meridian (L side). In Oriental Medicine, the spleen has functions of promoting water metabolism, transporting nutrients, and controlling blood. Mouth belongs to the spleen system according to Five element theory. Small intestine is related with mucositis symptoms including thirst and tongue ulcers. We will use sterile, disposable, filiform needles, size 0.16 (40Gauge) - 0.30 mm (30Gauge) in diameter and 15-40 mm long. Total number of acupuncture needles will be 8 (4 needles each side) and needles will be retained for 20 minutes. |
| Sham Acupuncture | Sham comparator | Procedure: Real Acupuncture, Procedure: Sham AcupunctureNewly diagnosed leukemia patients will be recruited from the large patient population on the Leukemia Inpatient Services who will be receiving high dose preperative regimens such as Busulfan + Cytarabine for marrow transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed with leukemia (such as acute myelogenous leukemia) and receiving chemotherapy for induction, consolidation or re-induction or high dose preparative regimen for bone marrow transplantation in the Johns Hopkins Oncology Inpatient Services
- Participation in standard leukemia-treatment regimens
- Expectation of survival of three weeks for completion of the study
Key exclusion criteria (5 listed)
- Acupuncture treatment within the previous 6 weeks
- Unable to achieve platelet count of at least 10,000 with platelet support
- Radiation therapy within one month of enrollment
- Pregnant women
- History of substance abuse, including alcohol and IV drug users
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 |
|---|---|---|
| Real Acupuncture | Procedure or surgery | Real Acupuncture, Sham Acupuncture |
| Sham AcupunctureSham needles are developed to exclude sham effect and to prove real acupuncture efficacy. We will use specifically retractable Park Sham Device (AcuPrime, Exeter, UK) for control group. Because this sham device gives the impression of insertion with telescopic needle body and some pricking sensation with a bunt needle tip. It is a valid control for many acupuncture trials as it doesn't penetrate skin and doesn't create active stimulation as much as real needles or acupressure. To avoid unnecessary stimulation of penetrating skin in this population, we plan to use non-penetrating sham device rather than penetrating non-acupuncture point with real needles as control intervention. All other procedures will be same as Real Acupuncture group except using non-penetrating sham needles on non-acupuncture points. After final session, we will ask all subjects in both groups which form of treatment each subject believe to have during study and will analyze blinding credibility. | Procedure or surgery | Real Acupuncture, Sham Acupuncture |
Primary outcome
Compliance
Time frame: 12 weeks
Retention/ dropout rate
Sham credibility rate
Time frame: 12 weeks
Frequency of any adverse effects
Time frame: 12 weeks
Bleeding, infection, bruising, etc
3 secondary outcomes
Pain levels
Time frame: 12 weeks
Mucositis Grade
Time frame: 12 weeks
Total amount of conventional analgesics used and Total days on Analgesic
Time frame: 12 weeks
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 8 Apr 2015.
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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.
Adrian S Dobs, MD MHS principal investigator
Johns Hopkins University
Sanghoon Lee, KMD PhD LAc study director
Johns Hopkins 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 Real Acupuncture in people with Mucositis and Pain, run by Johns Hopkins 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 3 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: withdrawn, as of the sponsor's last update on 8 Apr 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. 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?
Compliance (time frame: 12 weeks). The study lists 3 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 Apr 2015.