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Massage Therapy in Treating Patients With Cancer Pain
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082290
  Purpose

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.


Condition Intervention Phase
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: massage therapy
Procedure: pain therapy
Phase II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
Official Title: Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

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

Primary Outcome Measures:
  • Area-under-the-curve (AUC) pain for the first 24 hours after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesics medication use in chronic pain patients as measured by the Medication Quantification Scale (MQS) every 24 hours [ Designated as safety issue: No ]
  • Duration of massage effects, patient gender, referral source, expectancy and associations between changes in levels of arousal and changes in pain scores [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2003
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
  • Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
  • Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
  • Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain
  • Pain syndrome must be the result of cancer and/or cancer treatment

    • No postoperative or other acute procedural pain

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Concurrent pharmacologic pain therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082290

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Barrie R. Cassileth, PhD     212-639-8629        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Barrie R. Cassileth, PhD Memorial Sloan-Kettering Cancer Center
  More Information

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

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Barrie R. Cassileth )
Study ID Numbers: CDR0000476652, MSKCC-03046A
Study First Received: May 5, 2004
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00082290  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on January 15, 2009