PainPhase 2NCT00082290
Massage Therapy in Treating Patients With Cancer Pain
A Phase 2 study testing massage therapy, visit with a volunteer and period of quiet time in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- massage therapy, visit with a volunteer and period of quiet time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
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.
Read the 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.
- Being tested
- massage therapy, visit with a volunteer, period of quiet time, questionaire about pain
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage therapyOther
visit with a volunteerOther
period of quiet timeOther
questionaire about painBehavioural
| Study group | Role | What they receive |
|---|---|---|
| a massage | Experimental | About 45 minute massage Receives: Other: massage therapy; Behavioral: questionaire about pain |
| visit with a volunteer | Experimental | 45 minute visit Receives: Other: visit with a volunteer; Behavioral: questionaire about pain |
| period of quiet time | Experimental | 45 minutes of quiet time Receives: Other: period of quiet time; Behavioral: questionaire about pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in pain
A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2004 (estimated)
- Study startMay 2003
- Primary completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barrie R. Cassileth, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082290
- Sponsor's protocol ID
- 03-046
- Status last verified
- Dec 2015
- First submitted
- 5 May 2004
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00082290
- Acronym / sponsor ID
- 03-046
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- Primary completion
- Feb 2011 (actual)
- First posted
- 6 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a massage | Experimental | Other: massage therapy, Behavioral: questionaire about painAbout 45 minute massage |
| visit with a volunteer | Experimental | Other: visit with a volunteer, Behavioral: questionaire about pain45 minute visit |
| period of quiet time | Experimental | Other: period of quiet time, Behavioral: questionaire about pain45 minutes of quiet time |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage therapy | Other | a massage |
| visit with a volunteer | Other | visit with a volunteer |
| period of quiet time | Other | period of quiet time |
| questionaire about pain | Behavioural | a massage, period of quiet time, visit with a volunteer |
Primary outcome
reduction in pain
Time frame: 24 hours after treatment
A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrie R. Cassileth, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing massage therapy, visit with a volunteer and period of quiet time in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in pain (time frame: 24 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.