Clinical trial NCT00549835: Acupuncture for Mucositis Pain in Cancer Care
Official title: Acupuncture for Mucositis Pain in Cancer Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mucositis
Pain
Leukemia
Keywords: mucositis pain
cancer
pain
acupuncture
mucositis
cancer pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance
timeFrame: 12 weeks
measure: Sham credibility rate
timeFrame: 12 weeks
measure: Frequency of any adverse effects
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain levels
timeFrame: 12 weeks
measure: Mucositis Grade
timeFrame: 12 weeks
measure: Total amount of conventional analgesics used and Total days on Analgesic
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Adrian S Dobs, MD MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Sanghoon Lee, KMD PhD LAc
role: STUDY_DIRECTOR
References: