Acupuncture for Mucositis Pain in Cancer Care
Avainsanat
Abstrakti
Kuvaus
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.
Päivämäärät
| Viimeksi vahvistettu: | 02/28/2015 |
| Ensimmäinen lähetys: | 10/23/2007 |
| Arvioitu ilmoittautuminen lähetetty: | 10/23/2007 |
| Ensimmäinen lähetetty: | 10/25/2007 |
| Viimeisin päivitys lähetetty: | 04/06/2015 |
| Viimeisin päivitys lähetetty: | 04/07/2015 |
| Todellinen opintojen alkamispäivä: | 07/31/2007 |
| Arvioitu ensisijainen valmistumispäivä: | 09/30/2009 |
| Arvioitu tutkimuksen valmistumispäivä: | 09/30/2009 |
Ehto tai tauti
Interventio / hoito
Procedure: Real Acupuncture
Procedure: Sham Acupuncture
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Active Comparator: Real Acupuncture 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. | |
| Sham Comparator: Sham Acupuncture 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. |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | 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 |
Tulokset
Ensisijaiset tulosmittaukset
1. Compliance [12 weeks]
2. Sham credibility rate [12 weeks]
3. Frequency of any adverse effects [12 weeks]
Toissijaiset tulosmittaukset
1. Pain levels [12 weeks]
2. Mucositis Grade [12 weeks]
3. Total amount of conventional analgesics used and Total days on Analgesic [12 weeks]
