NCT00039793

Brief Summary

The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2001

Typical duration for phase_2

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

March 1, 2001

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

June 11, 2002

Last Update Submit

August 17, 2006

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsColorectal Neoplasms

Keywords

Cancer-related fatiguealternative medicinecancer rehabilitation /carefatiguehuman therapy evaluationphysical therapyneoplasm /cancer chemotherapyneoplasm /cancer palliative treatment

Interventions

Moderate-intensity and low-intensity bodywork therapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum
  • Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.
  • Have a primary oncologist
  • Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months

You may not qualify if:

  • Active skin rash or open cutaneous lesions.
  • History of venous thrombosis (or symptomatic varicosity)
  • Identification of a thrombosis using an ultrasound test of the legs.
  • Long term (\> 3 months) steroid medications for other medical conditions in past 5 years
  • Plans to move out of the study region within 6 months
  • Thyroid-stimulating hormone (TSH) level above the upper limit of normal
  • Hematocrit \<25%
  • Platelet count of \< 50,000
  • Patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. doi: 10.1016/j.ctim.2007.08.001. Epub 2007 Sep 21.

    PMID: 18534330DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsColorectal NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Avins, MD, MPH

    Osher Center for Integrative Medicine, University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Shelley Adler, PhD

    Osher Center for Integrative Medicine, University of California, San Francisco

  • Michael Patterson, MS

    Osher Center for Integrative Medicine, University of California, San Francisco

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 11, 2002

First Posted

June 13, 2002

Study Start

March 1, 2001

Study Completion

March 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(1)