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Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00060021
  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 Intervention
Cancer
Procedure: acupuncture therapy
Procedure: management of therapy complications
Procedure: pain therapy

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Acupuncture    Breast Cancer    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:   A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2003

Detailed 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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060021

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

Investigators
Study Chair:     Claude Sportes, MD     National Cancer Institute (NCI)    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000299048, NCI-03-C-0125
First Received:   May 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00060021
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
oral complications of cancer and cancer therapy  
pain  
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia  
chronic eosinophilic leukemia  
chronic idiopathic myelofibrosis  
chronic neutrophilic leukemia  
chronic phase chronic myelogenous leukemia  
de novo myelodysplastic syndromes  
disseminated neuroblastoma  
meningeal chronic myelogenous leukemia  
noncontiguous stage II adult diffuse large cell lymphoma  
noncontiguous stage II adult diffuse mixed cell lymphoma  
noncontiguous stage II adult diffuse small cleaved cell lymphoma  
noncontiguous stage II adult Burkitt lymphoma  
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
ovarian choriocarcinoma
ovarian embryonal carcinoma
ovarian yolk sac tumor
ovarian immature teratoma
ovarian mature teratoma
ovarian monodermal and highly specialized teratoma
ovarian polyembryoma
ovarian mixed germ cell tumor
poor prognosis metastatic gestational trophoblastic tumor

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Seminoma
Ovarian epithelial cancer
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Mucositis
Leukemia, B-cell, chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Myeloproliferative Disorders
Breast Neoplasms
Leukemia, Myeloid
Testicular Neoplasms
Carcinoma
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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