FatigueEXCAPNCT00815672
Exercise for Prostate Cancer Patients
A study testing Exercise in people with Fatigue, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to gain a better understanding of the mechanisms responsible for cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Fatigue
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 31 Dec 2018
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a primary diagnosis of prostate cancer
- Have a KPS of 60 or greater.
- Be receiving any form of treatment for their prostate cancer or have received some form of treatment (e.g. surgery, chemotherapy, radiation therapy, hormone therapy) in the last 10 years
- Have approval of physician and be able to read English.
- Be 21 years of age or older and give informed consent
Who cannot join
- Have bone metastases that preclude participation due to symptoms such as pain or location of the bone metastasis.
- Have physical limitations that contraindicate participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center, University of Rochester
Rochester, New York, 14642
About this study
Official title: The Influence of Home-based Aerobic and Resistance Exercise on Cancer-Related Fatigue, Strength, and Muscle Mass in Prostate Patients.
The purpose of this study is to gain a better understanding of the mechanisms responsible for cancer-related fatigue.
Read the detailed description
Numerous studies have shown that the vast majority of patients experience cancer-related fatigue (CRF) during cancer treatments. Research by our group showed that 71% percent of 84 prostate cancer patients reported CRF during radiation. Unlike fatigue caused by overexertion, CRF is a pervasive, whole-body experience that is not alleviated by rest or sleep and often lingers long after completing standard treatments like radiation therapy. It has a detrimental effect on patients' quality of life and can interfere with completion of prescribed treatment regimens. In addition, lasting fatigue for many patients impedes the resumption of normal life following treatments. Unfortunately, effective, well-accepted treatments for CRF are lacking. Although some research suggests that exercise may be a promising intervention for reducing CRF, physicians are still hesitant to prescribe exercise for fatigued patients, and, in fact, often encourage them to rest and conserve energy, which may be in exact opposition to what is needed.
One probable peripheral physiological mechanism that may affect the influence CRF is a loss of skeletal muscle mass, which, ultimately, effects weakness and strength. This muscle loss can result from deconditioning effects stemming from reduced physical activity resulting from cancer and its treatment. It is plausible that patients may enter radiation therapy with a certain degree of muscle loss, reduced strength and substantially decreased levels of physical activity as a result of their cancer diagnosis and the associated stress, surgical and systemic treatments, and/or the subsequent symptomology. Additionally, their physical activity may decline even further during radiation and escalate the loss of muscle and decreased strength. Recently, researchers have proposed that these deconditioning responses, as well as generalized inflammatory responses resulting from the cancer and/or its treatment result in skeletal muscle loss and strength deficits, which may play a significant role in the etiology of CRF. Although mild exercise can counteract deconditioning, current research has shown that cancer patients decrease the amount of physical activity they engage in after diagnosis as well as during and after treatment. Additionally, a substantial number of patients never return to prediagnosis levels of physical exercise and do not meet the minimal ACSM or CDC guidelines for achieving the health-related benefits (e.g., increased muscle mass, strength, and cardiorespiratory fitness) thought to be etiologically involved in CRF, suggesting the need for formal intervention.
We propose to test an individually tailored physical exercise intervention, including both aerobic and resistance exercise, for reducing CRF in prostate cancer patients receiving radiation therapy. The proposed research will provide detailed information on the efficacy and acceptance of a home-based aerobic and resistance exercise program for CRF among prostate cancer patients receiving radiation. Data regarding the influence of this intervention on potential factors related to CRF, including loss of strength, muscle atrophy and inflammatory biomarkers will be gathered. The purpose of the proposed study is to extend the positive findings from a feasibility study showing that our tailored home-based aerobic (walking) and progressive resistance exercise program was effective in reducing CRF and improving strength, skeletal muscle mass, aerobic capacity and quality of life in a small sample of prostate and breast cancer patients (N=38).
The Primary Aim of the study is to examine the influence of a home-based aerobic and progressive resistance exercise program on CRF in prostate cancer patients receiving radiation therapy. The proposed study is a phase II randomized, 2-arm, controlled clinical trial employing a repeated-measures design (baseline, post intervention, 3-month follow-up) that will accrue 122 male prostate cancer patients receiving radiation therapy.
This project builds upon very promising pilot data and includes a diverse research team with substantial experience in exercise interventions, survivorship, and cancer control research. This grant will allow us to discern the efficacy of a novel, tailored, home-based aerobic and resistance exercise intervention for reducing CRF among prostate cancer patients during radiation, and to identify potential factors (e.g., loss of strength, muscle atrophy, dysregulation of bodily immune function} that may contribute to the development of CRF that, in turn, can be more effectively targeted through tailoring future exercise interventions to improve the impact of these exercise interventions on reducing CRF. These results will have the direct potential to reduce the suffering experienced by prostate cancer patients during radiation treatments, and to positively impact future research in exercise and cancer control on side effect management, the practice of evidence-based medicine for the treatment of CRF, and, eventually, public health policy and oncology practice.
- Conditions
- Fatigue
- Being tested
- Exercise
- Keywords
- Exercise, Prostate cancer, Fatigue
- Medical subject headings
- Fatigue, Motor Activity, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Progressive walking and resistance exercise treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | No intervention | Usual Care: Standard care monitoring |
| Treatment arm 2 | Experimental | Home-based Exercise: Progressive walking and resistance exercise treatment. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue
The primary outcome measure for this study is CRF assessed by the FACIT-F fatigue subscale at the end of the 6th calendar week of the study.
Measured: 4.5 Months
Secondary outcomes (6)
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Strength
Strength: 7-10 repetition maximum test
Measured: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Skeletal Muscle Mass
Skeletal Muscle Mass: DEXA
Measured: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: QOL
QOL: Facit-F
Measured: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Sleep Quality
Sleep Quality: PSQI
Measured: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Self Esteem
Self Esteem: RSE
Measured: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Inflammatory Cytokines
Inflammatory Cytokines: Cytokine Specific ELISAs
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2007
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Karen Mustian, University of Rochester
- Investigators
- Karen Mustian, Ph.D., Principal investigator, James P. Wilmot Cancer Center, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815672
- Sponsor's protocol ID
- 1703DOD
- Acronym
- EXCAP
- Status last verified
- Nov 2018
- First submitted
- 29 Dec 2008
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Home-based Aerobic and Resistance Exercise on Cancer-Related Fatigue, Strength, and Muscle Mass in Prostate Patients.
- ClinicalTrials.gov ID
- NCT00815672
- Acronym / sponsor ID
- EXCAP / 1703DOD
- Conditions
- Fatigue
- Keywords
- Exercise, Prostate cancer, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Dec 2007
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Dec 2008 (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 gain a better understanding of the mechanisms responsible for cancer-related fatigue.
Detailed description
Numerous studies have shown that the vast majority of patients experience cancer-related fatigue (CRF) during cancer treatments. Research by our group showed that 71% percent of 84 prostate cancer patients reported CRF during radiation. Unlike fatigue caused by overexertion, CRF is a pervasive, whole-body experience that is not alleviated by rest or sleep and often lingers long after completing standard treatments like radiation therapy. It has a detrimental effect on patients' quality of life and can interfere with completion of prescribed treatment regimens. In addition, lasting fatigue for many patients impedes the resumption of normal life following treatments. Unfortunately, effective, well-accepted treatments for CRF are lacking. Although some research suggests that exercise may be a promising intervention for reducing CRF, physicians are still hesitant to prescribe exercise for fatigued patients, and, in fact, often encourage them to rest and conserve energy, which may be in exact opposition to what is needed.
One probable peripheral physiological mechanism that may affect the influence CRF is a loss of skeletal muscle mass, which, ultimately, effects weakness and strength. This muscle loss can result from deconditioning effects stemming from reduced physical activity resulting from cancer and its treatment. It is plausible that patients may enter radiation therapy with a certain degree of muscle loss, reduced strength and substantially decreased levels of physical activity as a result of their cancer diagnosis and the associated stress, surgical and systemic treatments, and/or the subsequent symptomology. Additionally, their physical activity may decline even further during radiation and escalate the loss of muscle and decreased strength. Recently, researchers have proposed that these deconditioning responses, as well as generalized inflammatory responses resulting from the cancer and/or its treatment result in skeletal muscle loss and strength deficits, which may play a significant role in the etiology of CRF. Although mild exercise can counteract deconditioning, current research has shown that cancer patients decrease the amount of physical activity they engage in after diagnosis as well as during and after treatment. Additionally, a substantial number of patients never return to prediagnosis levels of physical exercise and do not meet the minimal ACSM or CDC guidelines for achieving the health-related benefits (e.g., increased muscle mass, strength, and cardiorespiratory fitness) thought to be etiologically involved in CRF, suggesting the need for formal intervention.
We propose to test an individually tailored physical exercise intervention, including both aerobic and resistance exercise, for reducing CRF in prostate cancer patients receiving radiation therapy. The proposed research will provide detailed information on the efficacy and acceptance of a home-based aerobic and resistance exercise program for CRF among prostate cancer patients receiving radiation. Data regarding the influence of this intervention on potential factors related to CRF, including loss of strength, muscle atrophy and inflammatory biomarkers will be gathered. The purpose of the proposed study is to extend the positive findings from a feasibility study showing that our tailored home-based aerobic (walking) and progressive resistance exercise program was effective in reducing CRF and improving strength, skeletal muscle mass, aerobic capacity and quality of life in a small sample of prostate and breast cancer patients (N=38).
The Primary Aim of the study is to examine the influence of a home-based aerobic and progressive resistance exercise program on CRF in prostate cancer patients receiving radiation therapy. The proposed study is a phase II randomized, 2-arm, controlled clinical trial employing a repeated-measures design (baseline, post intervention, 3-month follow-up) that will accrue 122 male prostate cancer patients receiving radiation therapy.
This project builds upon very promising pilot data and includes a diverse research team with substantial experience in exercise interventions, survivorship, and cancer control research. This grant will allow us to discern the efficacy of a novel, tailored, home-based aerobic and resistance exercise intervention for reducing CRF among prostate cancer patients during radiation, and to identify potential factors (e.g., loss of strength, muscle atrophy, dysregulation of bodily immune function} that may contribute to the development of CRF that, in turn, can be more effectively targeted through tailoring future exercise interventions to improve the impact of these exercise interventions on reducing CRF. These results will have the direct potential to reduce the suffering experienced by prostate cancer patients during radiation treatments, and to positively impact future research in exercise and cancer control on side effect management, the practice of evidence-based medicine for the treatment of CRF, and, eventually, public health policy and oncology practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | No intervention | –Usual Care: Standard care monitoring |
| Treatment arm 2 | Experimental | Behavioral: ExerciseHome-based Exercise: Progressive walking and resistance exercise treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a primary diagnosis of prostate cancer
- Have a KPS of 60 or greater.
- Be receiving any form of treatment for their prostate cancer or have received some form of treatment (e.g. surgery, chemotherapy, radiation therapy, hormone therapy) in the last 10 years
- Have approval of physician and be able to read English.
- Be 21 years of age or older and give informed consent
Key exclusion criteria (2 listed)
- Have bone metastases that preclude participation due to symptoms such as pain or location of the bone metastasis.
- Have physical limitations that contraindicate participation.
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 |
|---|---|---|
| ExerciseProgressive walking and resistance exercise treatment | Behavioural | Treatment arm 2 |
Primary outcome
Cancer-related fatigue
Time frame: 4.5 Months
The primary outcome measure for this study is CRF assessed by the FACIT-F fatigue subscale at the end of the 6th calendar week of the study.
6 secondary outcomes
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Strength
Time frame: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Skeletal Muscle Mass
Time frame: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: QOL
Time frame: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Sleep Quality
Time frame: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Self Esteem
Time frame: 4.5 months
To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Inflammatory Cytokines
Time frame: 4.5 months
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 28 Aug 2019.
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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.
Karen Mustian, Ph.D. principal investigator
James P. Wilmot Cancer Center, University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fatigue, run by University of Rochester 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 2 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 28 Aug 2019. 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?
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: 4.5 Months). 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 28 Aug 2019; AzTrials last refreshed its copy on 3 Nov 2026.