Massage Therapy in Treating Patients With Cancer Pain - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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, 10065
Contact: Barrie R. Cassileth, PhD 212-639-8629

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Barrie R. Cassileth, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Barrie R. Cassileth )
Study ID Numbers:	CDR0000476652, MSKCC-03046A
Study First Received:	May 5, 2004
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00082290 History of Changes
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 July 02, 2009