Acupuncture for Mucositis Pain in Cancer Care

NCT00549835 | Withdrawn

• 1 other identifier: NA_00008179
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis; Pain; Leukemia

Keywords

mucositis pain; cancer; pain; acupuncture; mucositis; cancer pain

Outcome Measures

Primary Outcomes (3)

• Compliance

  Retention/ dropout rate

  12 weeks

• Sham credibility rate

  12 weeks

• Frequency of any adverse effects

  Bleeding, infection, bruising, etc

  12 weeks

Secondary Outcomes (3)

• Pain levels

  12 weeks

• Mucositis Grade

  12 weeks

• Total amount of conventional analgesics used and Total days on Analgesic

  12 weeks

Study Arms (2)

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.

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.

Procedure: Real Acupuncture; Procedure: Sham Acupuncture

Interventions

Real Acupuncture PROCEDURE

Real Acupuncture; Sham Acupuncture

Sham Acupuncture PROCEDURE

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.

Real Acupuncture; Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Mucositis; Pain; Leukemia; Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Adrian S Dobs, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Sanghoon Lee, KMD PhD LAc

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 8, 2015

Record last verified: 2015-03

Locations

US (1)