Acupuncture for Mucositis Pain in Cancer Care

Pain Clinical Trial

Official title:

Acupuncture for Mucositis Pain in Cancer Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00549835
• Other study ID #: NA_00008179
• Status: Withdrawn
• Phase: N/A
• First received: October 24, 2007
• Last updated: April 7, 2015
• Start date: August 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia
• Mucositis
• Pain

Intervention

Procedure:
• Real Acupuncture

• Sham Acupuncture
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Retention/ dropout rate	12 weeks	No
Primary	Sham credibility rate		12 weeks	No
Primary	Frequency of any adverse effects	Bleeding, infection, bruising, etc	12 weeks	Yes
Secondary	Pain levels		12 weeks	No
Secondary	Mucositis Grade	CTC Scoring, Hopkins Scoring; Oral Mucositis Daily Questionnaire (OMDQ)	12 weeks	No
Secondary	Total amount of conventional analgesics used and Total days on Analgesic		12 weeks	No