NCT00060021

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2004

First QC Date

May 6, 2003

Last Update Submit

April 29, 2015

Conditions

Cancer

Keywords

oral complicationspainaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesdisseminated neuroblastomameningeal chronic myelogenous leukemianoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomaovarian choriocarcinomaovarian embryonal carcinomaovarian yolk sac tumorovarian immature teratomaovarian mature teratomaovarian monodermal and highly specialized teratomaovarian polyembryomaovarian mixed germ cell tumorhigh risk metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent malignant testicular germ cell tumorrefractory chronic lymphocytic leukemiarelapsing chronic myelogenous leukemiarefractory hairy cell leukemiarefractory multiple myelomasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomastage II ovarian epithelial cancerstage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III ovarian epithelial cancerstage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV breast cancerstage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV ovarian epithelial cancertesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and seminomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and yolk sac tumortesticular embryonal carcinoma and seminomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinomatesticular teratomatesticular yolk sac tumor and teratoma with seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumorrecurrent adult acute myeloid leukemiatesticular choriocarcinomaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

acupuncture therapyPROCEDURE
management of therapy complicationsPROCEDURE
pain therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

NeoplasmsPainLeukemia, Myeloid, Accelerated PhaseBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhasePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialTesticular NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaBreast NeoplasmsCarcinoma, EmbryonalSeminomaTeratomaEndodermal Sinus TumorTeratoma, TesticularLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal Zone

Interventions

Acupuncture TherapyAnalgesia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphomaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGerminomaMesonephromaMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAnesthesia and Analgesia

Study Officials

  • Claude Sportes, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

March 1, 2003

Last Updated

April 30, 2015

Record last verified: 2004-04

Locations

US(1)