Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation
This study is currently recruiting patients.
Purpose
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.
Condition
|
Treatment or Intervention |
Cancer oral complications of cancer and cancer therapy Pain
|
Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: complications of therapy assessment/management Procedure: pain therapy Procedure: supportive care/therapy
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Pain
Study Type: Interventional
Study Design: Treatment
Official Title: Randomized Study of Acupuncture for Mucositis-Related Pain Secondary to High-Dose Chemotherapy in Patients Undergoing Hematopoietic
Stem Cell Transplantation
Further Study Details:
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
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
Hematopoietic
- No history of bleeding disorders
Hepatic
Renal
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
Radiotherapy
Surgery
Other
- No concurrent anticoagulant therapy
Location
and Contact
Information
Maryland Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,
Maryland,
20892-1182,
United States; Recruiting
Patient Recruitment
888-NCI-1937
Study chairs or principal investigators
Claude Kasten-Sportes, MD, Study Chair, National Cancer Institute (NCI)
More Information
Study ID Numbers:
CDR0000299048; NCI-03-C-0125
Record last reviewed:
April 2003
Record first received:
May 6, 2003
ClinicalTrials.gov Identifier:
NCT00060021Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29