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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Area-under-the-curve (AUC) pain for the first 24 hours after treatment

Safety Issue:

No

Principal Investigator

Barrie R. Cassileth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000476652

NCT ID:

NCT00082290

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pain

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021