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Massage Therapy in Treating Patients With Cancer Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00082290
First received: May 5, 2004
Last updated: March 17, 2011
Last verified: July 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

Resource links provided by NLM:


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
Primary Completion Date: February 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082290

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Barrie R. Cassileth, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Barrie R. Cassileth, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00082290     History of Changes
Other Study ID Numbers: CDR0000476652, MSKCC-03046A
Study First Received: May 5, 2004
Last Updated: March 17, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014