Clinical trial · Interventional
Acupuncture for Mucositis Pain in Cancer Care
NCT00549835CI-TRIAL-00017424withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Mucositis | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Real Acupuncture | Procedure | — | UNRESOLVED |
| Sham Acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Real Acupuncture
- description
- 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.
- interventionNames
- Procedure: Real Acupuncture
- Procedure: Sham Acupuncture
- type
- SHAM_COMPARATOR
- label
- Sham Acupuncture
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.