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

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ClinicalTrials.gov Identifier: NCT00060021
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : April 30, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Procedure: acupuncture therapy Procedure: management of therapy complications Procedure: pain therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
Genetic and Rare Diseases Information Center resources: Multiple Myeloma Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Neuroblastoma Diffuse Large B-Cell Lymphoma Mycosis Fungoides Hodgkin Lymphoma Embryonal Carcinoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Myelodysplastic/myeloproliferative Disease Choriocarcinoma Gestational Trophoblastic Tumor Burkitt Lymphoma Ovarian Germ Cell Tumor Testicular Seminoma Chronic Neutrophilic Leukemia Testicular Yolk Sac Tumor Polyembryoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060021


Locations
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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: Claude Sportes, MD National Cancer Institute (NCI)
More Information
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ClinicalTrials.gov Identifier: NCT00060021    
Other Study ID Numbers: CDR0000299048
NCI-03-C-0125
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
oral complications
pain
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
primary 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
high risk metastatic gestational trophoblastic tumor
Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases