Breast CancerRTTM301NCT01071109
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
A study testing Therapeutic Massage in people with Breast Cancer and Fatigue, run by Floyd Memorial Hospital and Health Services at 1 site in United States.
Trial summary
A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue, Insomnia
- What is being tested?
- Therapeutic Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2012
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients and
- > or = 18 years of age and
- diagnosed with breast cancer and
- undergoing radiation therapy and
- willing to follow protocol requirements
Who cannot join
- Stage IV disease or
- Presence of an underlying disease that is anticipated to be fatal w/in 6 mo
- Long term steroid medications in the past year or
- Plans to move out of study region within six months or
- Receiving regular body work over the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
FMHHS Cancer Care Center
New Albany, Indiana, 47150
Judith G Myers, PhD, 812-941-2695, judymyer@ius.edu
Krystal S Angevine, MSW, 812-949-5989, kangevine@fmhhs.com
About this study
A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population.
The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy.
The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.
- Conditions
- Breast Cancer, Fatigue, Insomnia
- Being tested
- Therapeutic Massage
- Keywords
- Therapeutic massage, massage, inflammation, fatigue, insomnia, radiation therapy, breast cancer, Breast Cancer patients receiving radiation therapy
- Medical subject headings
- Breast Neoplasms, Fatigue, Sleep Initiation and Maintenance Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic MassageProcedure or surgery
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Massage | Experimental | Not described Receives: Procedure: Therapeutic Massage |
| No therapeutic massage | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.
Measured: Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)
Secondary outcomes (1)
Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).
Measured: Baseline, End of Treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Floyd Memorial Hospital and Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Investigators
- Judith G Myers, PhD, Principal investigator, Indiana University Southeast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071109
- Sponsor's protocol ID
- RTTM301
- Acronym
- RTTM301
- Status last verified
- Feb 2010
- First submitted
- 16 Feb 2010
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT01071109
- Acronym / sponsor ID
- RTTM301 / RTTM301
- Conditions
- Breast Cancer, Fatigue, Insomnia
- Keywords
- Therapeutic massage, massage, inflammation, fatigue, insomnia, radiation therapy, breast cancer, Breast Cancer patients receiving radiation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Floyd Memorial Hospital and Health ServicesUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 19 Feb 2010 (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.
A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population.
The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy.
The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Massage | Experimental | Procedure: Therapeutic Massage |
| No therapeutic massage | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients and
- > or = 18 years of age and
- diagnosed with breast cancer and
- undergoing radiation therapy and
- willing to follow protocol requirements
Key exclusion criteria (5 listed)
- Stage IV disease or
- Presence of an underlying disease that is anticipated to be fatal w/in 6 mo
- Long term steroid medications in the past year or
- Plans to move out of study region within six months or
- Receiving regular body work over the past six 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 |
|---|---|---|
| Therapeutic MassageTherapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage | Procedure or surgery | Therapeutic Massage |
Primary outcome
Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.
Time frame: Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)
1 secondary outcome
Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).
Time frame: Baseline, End of Treatment (6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
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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.
Judith G Myers, PhD principal investigator
Indiana University Southeast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Massage in people with Breast Cancer and Fatigue, run by Floyd Memorial Hospital and Health Services 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Feb 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith G Myers, PhD (812-941-2695, judymyer@ius.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time. (time frame: Baseline, End of Treatment (6 weeks), End of Study (3 months after End of 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 19 Feb 2010.