Breast Cancer Clinical Trial
Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation
Summary
RATIONALE: Acupuncture may be effective in relieving mucositis-related pain caused by chemotherapy in patients undergoing stem cell transplantation.
PURPOSE: Randomized clinical trial to study the effectiveness of acupuncture in treating mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem cell transplantation.
Full Description
OBJECTIVES:
Compare the efficacy of acupuncture vs placebo acupuncture in alleviating mucositis-related pain secondary to high-dose chemotherapy, as assessed by total cumulative dose of opioids used and subjective pain scores, in patients undergoing hematopoietic stem cell transplantation.
Compare the overall number of patients requiring opioid therapy in these 2 intervention groups.
Compare the nausea and vomiting scores of patients in these 2 intervention groups.
Compare the sedation score of patients in these 2 intervention groups.
Compare the use of other psychotropic medications (e.g., anxiolytics or hypnotics) in patients in these 2 intervention groups.
Compare the need for total parenteral nutrition (TPN) and the number of days on TPN experienced by patients in these 2 intervention groups.
Compare pruritus and the need for symptomatic treatment in patients in these 2 intervention groups.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to 9-phenylthiocarbamide/6-n-propylthiouracil (PROP) tasting ability (super-tasters vs non-super-tasters). Patients are randomized to 1 of 2 treatment arms.
Arm I: Beginning immediately after the development of mucositis pain, patients undergo acupuncture over 30 minutes once daily. Patients also receive standard pain management. Treatment continues until pain is completely resolved in the absence of unacceptable toxicity.
Arm II: Patients undergo placebo acupuncture and receive standard pain management as in arm I.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Must be undergoing hematopoietic stem cell transplantation (HSCT) through one of the following means:
Concurrent enrollment on a HSCT protocol with the Experimental Transplantation & Immunology Branch (ETIB) at the NCI Center for Clinical Research*
Receiving HSCT as a compassionate exemption following the clinical guidelines of an ETIB protocol*
Directly observed oral or pharyngeal mucositis and/or suspected esophageal mucositis after high-dose chemotherapy
No pain unrelated to mucositis requiring use of potent analgesics prior to initiation of high-dose chemotherapy NOTE: *Protocol must be known to generate more than 50% incidence of high-dose chemotherapy-induced mucositis
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
No history of bleeding disorders
Hepatic
PT and PTT normal
Renal
Not specified
Other
No history or evidence of drug addiction or drug-seeking behavior
No skin infection at the sites of acupuncture points
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
Chemotherapy
See Disease Characteristics
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
No concurrent anticoagulant therapy
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Bethesda Maryland, 20892, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.