Cancer Related FatiguePhase 2NCT01926678
Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer Survivors
A Phase 2 study testing Swedish massage therapy and Light touch therapy in people with Cancer Related Fatigue, run by Emory University at 1 site in United States.
Trial summary
With approximately 12 million cancer survivors today in the United States alone, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cancer Related Fatigue
- What is being tested?
- Swedish massage therapy and Light touch therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- ages 18 to 65 (women above the age of 65 may be included at PI discretion)
- • with Stage 0-III breast cancer, status-post surgery treated with standard chemotherapy/chemoprevention and/or radiation.
- • Patients will be between 3 months and 4-years post treatment. Ongoing chemoprevention therapy is permissible. Based on ICD-10 proposed criteria, a diagnosis of CRF will require evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of comorbid psychiatric disorders (schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium or OCD).
- Brief Fatigue Inventory (BFI) score of >25.
- Satisfactory results of screening safety labs, urine pregnancy test and drug test.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Women of reproductive capability will be enrolled, but each woman needs to discuss with the study team the method of birth control used and if the method is a reliable and effective method for her. If a woman becomes pregnant during the course of active study participation, she must agree prior to enrolling in the study that she will report the pregnancy to the study team. With a confirmed pregnancy, the subject will no longer receive the assigned treatment, but will continue to be followed per protocol.
Who cannot join
- Inability to lay supine for one hour at a time, given the nature of the massage intervention.
- Subjects who are actively suicidal or homicidal.
- Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 MCU/mL), uncontrolled pain, medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and sleep apnea.
- Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment including: opioids, sedating anti-histamines, antidepressants, anxiolytics or neuroleptics.
- Body-mass index less than 18.5 (kg/m2).
- • Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days.
Show all 16Show fewer
- Unable to comply with the protocol for any reason.
- Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked.
- Other exclusion criteria include: illicit drug use, shift work, current dieting, excessive regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months.
- Subjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditions.
- Subjects who have massages on a regular basis. Regular massage usage will be operationally defined as receiving 4 or more massages/year for the last 5 years.
- Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem. However, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine.
- Adults over the age of 65 will generally be excluded from the study. This population tends to undergo changes in the physiological parameters we are evaluating. Therefore, inclusion of this population would skew various biological measures and this pilot investigation does not have a large enough sample size to control for such variability it. Older subjects could be included at the discretion of the PI.
- People unable to read and understand the informed consent document because of language difficulties.
- Women who are pregnant or lactating.
- Women who become pregnant while enrolled will be discontinued from the study and will be instructed to exercise, which is the standard recommendation for cancer-related fatigue. Inability or unwillingness of individual to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer
With approximately 12 million cancer survivors today in the United States alone, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Basic research has shown that activation of the immune system can cause potent changes in behavior including reduced activity, fatigue, and decreased social behavior. Furthermore, research over the last decade has found a relationship between levels of CRF with increased inflammation. Thus, study of therapies that may decrease immune system activation in the setting of CRF represents a possible target for intervention. Massage therapy is one of the fastest growing alternative therapies and has a high rate of acceptance for symptom management among cancer patients. Massage has been shown in smaller studies with cancer patients to modulate the immune system. Moreover, massage has been demonstrated to significantly decrease markers of immune system activation in normal subjects. There are no published randomized controlled trials examining either the role of massage as an intervention primarily for CRF or investigating whether massage related decreases in immune system activation are responsible for improvement in CRF. This proposal investigates the effects of massage therapy on CRF among breast cancer survivors. The investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF compared to a light touch condition and wait list control. The investigators' secondary hypothesis is that SMT will decrease CRF by reducing immune system activation. The investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of life among cancer survivors.
- Conditions
- Cancer Related Fatigue
- Being tested
- Swedish massage therapy, Light touch therapy
- Keywords
- swedish massage, fatigue, light touch, inflammation
- Medical subject headings
- Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish massage therapyOther
Light touch therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Swedish massage therapy | Experimental | Swedish massage therapy once per week for 6 weeks Receives: Other: Swedish massage therapy |
| Light touch therapy | Active comparator | Light touch therapy once per week for 6 weeks Receives: Other: Light touch therapy |
| Wait list | Other | A 6 week wait list, followed by randomization to massage therapy or light touch therapy once per week for 6 weeks Receives: Other: Swedish massage therapy; Other: Light touch therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-Related Fatigue
The primary aim of this study is to determine whether a 6-week Swedish massage therapy (SMT) intervention can decrease cancer-related fatigue, as measured by the Multidimensional Fatigue Inventory (MFI), among breast cancer survivors who have received both radiation and chemotherapy and have CRF. We hypothesize that SMT will decrease fatigue more than light touch (LT) or a wait list control (WLC) condition as assessed by the MFI.
Measured: 6 weeks
Secondary outcomes (1)
Inflammation
A secondary aim of this study is to determine whether the hypothesized decrease in cancer-related fatigue is due to Swedish massage therapy modulating the immune system of subjects with cancer-related fatigue to decrease chronic inflammation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mark H. Rapaport, Emory University
- Investigators
- Mark H Rapaport, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926678
- Sponsor's protocol ID
- IRB00062853
- Other IDs
- R21AT007090
- Status last verified
- Jul 2016
- First submitted
- 19 Aug 2013
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer
- ClinicalTrials.gov ID
- NCT01926678
- Acronym / sponsor ID
- IRB00062853
- Conditions
- Cancer Related Fatigue
- Keywords
- swedish massage, fatigue, light touch, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI)
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Aug 2013 (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.
With approximately 12 million cancer survivors today in the United States alone, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Basic research has shown that activation of the immune system can cause potent changes in behavior including reduced activity, fatigue, and decreased social behavior. Furthermore, research over the last decade has found a relationship between levels of CRF with increased inflammation. Thus, study of therapies that may decrease immune system activation in the setting of CRF represents a possible target for intervention. Massage therapy is one of the fastest growing alternative therapies and has a high rate of acceptance for symptom management among cancer patients. Massage has been shown in smaller studies with cancer patients to modulate the immune system. Moreover, massage has been demonstrated to significantly decrease markers of immune system activation in normal subjects. There are no published randomized controlled trials examining either the role of massage as an intervention primarily for CRF or investigating whether massage related decreases in immune system activation are responsible for improvement in CRF. This proposal investigates the effects of massage therapy on CRF among breast cancer survivors. The investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF compared to a light touch condition and wait list control. The investigators' secondary hypothesis is that SMT will decrease CRF by reducing immune system activation. The investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of life among cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Swedish massage therapy | Experimental | Other: Swedish massage therapySwedish massage therapy once per week for 6 weeks |
| Light touch therapy | Active comparator | Other: Light touch therapyLight touch therapy once per week for 6 weeks |
| Wait list | Other | Other: Swedish massage therapy, Other: Light touch therapyA 6 week wait list, followed by randomization to massage therapy or light touch therapy once per week for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women
- ages 18 to 65 (women above the age of 65 may be included at PI discretion)
- • with Stage 0-III breast cancer, status-post surgery treated with standard chemotherapy/chemoprevention and/or radiation.
- • Patients will be between 3 months and 4-years post treatment. Ongoing chemoprevention therapy is permissible. Based on ICD-10 proposed criteria, a diagnosis of CRF will require evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of comorbid psychiatric disorders (schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium or OCD).
- Brief Fatigue Inventory (BFI) score of >25.
Key exclusion criteria (16 listed)
- Inability to lay supine for one hour at a time, given the nature of the massage intervention.
- Subjects who are actively suicidal or homicidal.
- Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 MCU/mL), uncontrolled pain, medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and sleep apnea.
- Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment including: opioids, sedating anti-histamines, antidepressants, anxiolytics or neuroleptics.
- Body-mass index less than 18.5 (kg/m2).
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 |
|---|---|---|
| Swedish massage therapy | Other | Swedish massage therapy, Wait list |
| Light touch therapy | Other | Light touch therapy, Wait list |
Primary outcome
Cancer-Related Fatigue
Time frame: 6 weeks
The primary aim of this study is to determine whether a 6-week Swedish massage therapy (SMT) intervention can decrease cancer-related fatigue, as measured by the Multidimensional Fatigue Inventory (MFI), among breast cancer survivors who have received both radiation and chemotherapy and have CRF. We hypothesize that SMT will decrease fatigue more than light touch (LT) or a wait list control (WLC) condition as assessed by the MFI.
1 secondary outcome
Inflammation
Time frame: 6 weeks
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 11 Jul 2016.
Related trials for Cancer Related Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
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.
Mark H Rapaport, MD principal investigator
Emory University
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 Swedish massage therapy and Light touch therapy in people with Cancer Related Fatigue, run by Emory University 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 8 inclusion and 16 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 11 Jul 2016. 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?
Cancer-Related Fatigue (time frame: 6 weeks). 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 11 Jul 2016.