NCT00253708

Brief Summary

RATIONALE: Massage therapy may help relieve symptoms associated with cancer. It is not yet known which type of massage therapy is more effective in treating the symptoms of patients with cancer. PURPOSE: This randomized clinical trial is studying different types of massage therapy to compare how well they work in treating the symptoms of patients with locally advanced or metastatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

June 1, 2017

Enrollment Period

8.1 years

First QC Date

November 11, 2005

Results QC Date

March 30, 2017

Last Update Submit

June 29, 2017

Conditions

Cancer

Keywords

depressionnausea and vomitingpainpsychosocial effects of cancer and its treatmentstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerstage III gastric cancerstage III esophageal cancerlocalized unresectable adult primary liver cancerstage III colon cancerstage IV renal cell cancerstage IV bladder cancerstage IV prostate cancerstage IV breast cancerstage IV ovarian epithelial canceradvanced adult primary liver cancerstage IV melanomastage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerrecurrent small cell lung cancerrecurrent adult primary liver cancerrecurrent colon cancerrecurrent esophageal cancerrecurrent gastric cancerrecurrent non-small cell lung cancerrecurrent bladder cancerrecurrent breast cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent prostate cancerrecurrent renal cell cancerrecurrent melanoma

Outcome Measures

Primary Outcomes (3)

  • Pain

    0=no pain to 10=most severe pain

    From baseline to 1 week and from baseline to one month

  • Anxiety

    0=no anxiety to 10=most severe anxiety

    From baseline to 1 week and from baseline to 1 month

  • Alertness

    0=not at all alert to 10=most alert

    From baseline to 1 week and from baseline to 1 month

Secondary Outcomes (4)

  • Quality of Life: Physical Well-being

    From baseline to 1 week and from baseline to 1 month

  • Quality of Life: Psychological Well-being

    From baseline to 1 week and from baseline to 1 month

  • Quality of Life: McGill Total

    From baseline to 1 week and from baseline to 1 month

  • Sleep

    From baseline to 1 week and from baseline to 1 month

Study Arms (3)

massage

EXPERIMENTAL

Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

Procedure: management of therapy complicationsProcedure: massage therapyProcedure: pain therapyProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

no-touch control

ACTIVE COMPARATOR

Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

Procedure: management of therapy complicationsProcedure: massage therapyProcedure: pain therapyProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

Usual care

NO INTERVENTION

Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment

Interventions

management of therapy complicationsPROCEDURE
massageno-touch control
massage therapyPROCEDURE
massageno-touch control
pain therapyPROCEDURE
massageno-touch control
psychosocial assessment and carePROCEDURE
massageno-touch control
quality-of-life assessmentPROCEDURE
massageno-touch control

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid cancer with evidence of metastases
  • Receiving treatment at Beth Israel Deaconess Medical Center (BIDMC)
  • Must reside ≤ 25 miles from BIDMC

You may not qualify if:

  • Patient to sick to be interviewed
  • Absence of severe symptoms
  • Participating in another trial
  • Language barrier
  • MD does not provide permission
  • Expired prior to consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Toth M, Marcantonio ER, Davis RB, Walton T, Kahn JR, Phillips RS. Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial. J Altern Complement Med. 2013 Jul;19(7):650-6. doi: 10.1089/acm.2012.0466. Epub 2013 Jan 31.

    PMID: 23368724RESULT

MeSH Terms

Conditions

NeoplasmsDepressionNauseaVomitingPainCarcinoma, Non-Small-Cell LungStomach NeoplasmsEsophageal NeoplasmsColonic NeoplasmsCarcinoma, Renal CellUrinary Bladder NeoplasmsProstatic NeoplasmsBreast NeoplasmsCarcinoma, Ovarian EpithelialMelanomaSmall Cell Lung CarcinomaCarcinoma, Hepatocellular

Interventions

MassageAnalgesiaPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsLiver NeoplasmsLiver Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAnesthesia and AnalgesiaHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

Small sample size limited statistical power. Pre-post intervention data collection was not blinded. Patient bias in massage group. Heterogeneity in type and stage of cancer may have resulted in variation of the effects of the interventions.

Results Point of Contact

Title
Russell S. Phillips, MD
Organization
Beth Israel Deaconess Medical Center
Russell_phillips@hms.harvard.edu
6174322222

Study Officials

  • Russell S. Phillips, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was designed to assess the feasibility and effectiveness of massage for patients with cancer-related pain
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

December 1, 2004

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 7, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)