Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10065


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.


Study summary:

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.


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


Study is Available At:


Original ID:

03-046


NCT ID:

NCT00082290


Secondary ID:


Study Acronym:


Brief Title:

Massage Therapy in Treating Patients With Cancer Pain


Official Title:

Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

92


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barrie R. Cassileth, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Study Dates

Start Date:May 2003
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 17, 2015
First Received Date:May 5, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:reduction in pain
Time Frame:24 hours after treatment
Safety Issues:False
Description:A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

Study Interventions

Intervention Type:Other
Name:massage therapy
Arm Name:a massage
Intervention Type:Other
Name:visit with a volunteer
Arm Name:visit with a volunteer
Intervention Type:Other
Name:period of quiet time
Arm Name:period of quiet time
Intervention Type:Behavioral
Name:questionaire about pain
Arm Name:a massage

Study Arms

Study Arm Type:Experimental
Arm Name:a massage
Description:About 45 minute massage
Study Arm Type:Experimental
Arm Name:visit with a volunteer
Description:45 minute visit
Study Arm Type:Experimental
Arm Name:period of quiet time
Description:45 minutes of quiet time

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.