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Massage Therapy in Treating Patients With Cancer Pain

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00082290
Enrollment
92
Registered
2004-05-06
Start date
2003-05-31
Completion date
Unknown
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, pain

Brief summary

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.

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.

Interventions

OTHERmassage therapy
OTHERvisit with a volunteer
OTHERperiod of quiet time
BEHAVIORALquestionaire about pain

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
reduction in pain24 hours after treatmentA mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026