Breast NeoplasmsPhase 2NCT00039793
Massage Therapy for Cancer-Related Fatigue
A Phase 2 study testing Moderate-intensity and low-intensity bodywork therapy in people with Breast Neoplasms and Ovarian Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms
- What is being tested?
- Moderate-intensity and low-intensity bodywork therapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Mar 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum
- Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.
- Have a primary oncologist
- Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months
Who cannot join
- Active skin rash or open cutaneous lesions.
- History of venous thrombosis (or symptomatic varicosity)
- Identification of a thrombosis using an ultrasound test of the legs.
- Long term (> 3 months) steroid medications for other medical conditions in past 5 years
- Plans to move out of the study region within 6 months
- Thyroid-stimulating hormone (TSH) level above the upper limit of normal
Show all 9Show fewer
- Hematocrit <25%
- Platelet count of < 50,000
- Patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94143
About this study
The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.
Read the detailed description
The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being.
The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. This study will determine efficacy, functioning, perceptions of fatigue, and quality of life. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions.
- Being tested
- Moderate-intensity and low-intensity bodywork therapy
- Keywords
- Cancer-related fatigue, alternative medicine, cancer rehabilitation /care, fatigue, human therapy evaluation, physical therapy, neoplasm /cancer chemotherapy, neoplasm /cancer palliative treatment
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity and low-intensity bodywork therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2002 (estimated)
- Study startMar 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Andrew Avins, MD, MPH, Principal investigator, Osher Center for Integrative Medicine, University of California, San FranciscoShelley Adler, PhD, Osher Center for Integrative Medicine, University of California, San FranciscoMichael Patterson, MS, Osher Center for Integrative Medicine, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039793
- Sponsor's protocol ID
- R21AT000348-01
- Status last verified
- Jul 2006
- First submitted
- 11 Jun 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. doi: 10.1016/j.ctim.2007.08.001. Epub 2007 Sep 21.
PubMed 18534330
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Therapy for Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT00039793
- Acronym / sponsor ID
- R21AT000348-01
- Keywords
- Cancer-related fatigue, alternative medicine, cancer rehabilitation /care, fatigue, human therapy evaluation, physical therapy, neoplasm /cancer chemotherapy, neoplasm /cancer palliative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Mar 2004
- First posted
- 13 Jun 2002 (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.
The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.
Detailed description
The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being.
The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. This study will determine efficacy, functioning, perceptions of fatigue, and quality of life. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum
- Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.
- Have a primary oncologist
- Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months
Key exclusion criteria (9 listed)
- Active skin rash or open cutaneous lesions.
- History of venous thrombosis (or symptomatic varicosity)
- Identification of a thrombosis using an ultrasound test of the legs.
- Long term (> 3 months) steroid medications for other medical conditions in past 5 years
- Plans to move out of the study region within 6 months
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 |
|---|---|---|
| Moderate-intensity and low-intensity bodywork therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 Aug 2006.
- Derived from this study: PubMed 18534330Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. doi: 10.1016/j.ctim.2007.08.001. Epub 2007 Sep 21.
- Click here for more information about how to contact this studyLink provided by the sponsor.
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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.
Andrew Avins, MD, MPH principal investigator
Osher Center for Integrative Medicine, University of California, San Francisco
Shelley Adler, PhD
Osher Center for Integrative Medicine, University of California, San Francisco
Michael Patterson, MS
Osher Center for Integrative Medicine, University of California, San Francisco
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 Moderate-intensity and low-intensity bodywork therapy in people with Breast Neoplasms and Ovarian Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) 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?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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 Aug 2006. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00039793, which also lists 1 linked publication.
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 Aug 2006.