Cancer Related FatigueNCT02846389
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
A study testing Moderate Exercise in people with Cancer Related Fatigue, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cancer Related Fatigue
- What is being tested?
- Moderate Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2016to 3 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between the ages of 18 and 75 years
- histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
- radiation therapy naïve
- sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
- ambulatory
- negative serum pregnancy test and not planning to become pregnant in the next three months
- able to provide meaningful consent.
- Patients must have been deemed by their medical oncologist or internist that they "may participate in [this] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.
Who cannot join
- younger than 18 or older than 75 years
- no histological confirmation of breast cancer
- prior breast, chest, or pelvic radiotherapy
- concurrent chemotherapy
- distant metastases
- physical limitations that contraindicate participation in low to moderate intensity exercise
Show all 9Show fewer
- positive pregnancy test
- currently engaged in moderate to vigorous physical activity
- psychiatric disorder which would render the participant unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.
Read the detailed description
Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.
- Conditions
- Cancer Related Fatigue
- Being tested
- Moderate Exercise
- Keywords
- Radiation therapy for Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate ExerciseOther
Aerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Exercise | Experimental | Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). Receives: Other: Moderate Exercise |
| Control Group | No intervention | No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
The Functional Assessment of Chronic Illness Therapy (FACIT) is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point likert scale, with score ranging from 0 to 52 (52 being the total score allowed). The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.
Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reversed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.
Measured: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
Serum hsCRP will be measured on the Vitros 5,1 FS Chemistry platform via an immunoassay with a reportable range of 0.10 -15.00 mg/L, and intra- and inter-assay CVs of 1.8-4.0%. Change is reported based on the difference in the group mean of Serum hsCRP level between baseline and T4 visit.
Measured: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. Change is reported based on the difference in the group mean of Serum fibrinogen level between baseline and T4 visit.
Measured: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. Change is reported based on the difference in the group mean of ferritin levels between baseline and T4 visit.
Measured: Baseline, 4 weeks into RT
Secondary outcomes (1)
Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.
The Health-related quality of life (HRQOL) measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). Functional Assessment of Cancer Therapy (FACT-B) is a breast cancer specific module that will be used to reflect patients' concerns; moreover, they are reliable, reproducible, and have been validated in numerous studies. Score ranging from 0 to 148 (148 being the total score allowed).
Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reveresed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.
Change in the group sum of the FACT score between baseline and T4 visit.
Measured: Baseline, 4 weeks into RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start21 Jun 2016
- Primary completion3 Dec 2017
- Study completion3 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Cancer Related FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Lombardi Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Brett Lewis, M.D., Ph.D, Principal investigator, Hackensack UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846389
- Sponsor's protocol ID
- Pro2016-0162
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2016
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013 Mar 28;13:162. doi: 10.1186/1471-2407-13-162.
PubMed 23537231Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128.
PubMed 12192016Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2.
PubMed 12128109Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
PubMed 9469327Bagshaw MA, Kaplan ID, Cox RC. Prostate cancer. Radiation therapy for localized disease. Cancer. 1993 Feb 1;71(3 Suppl):939-52. doi: 10.1002/1097-0142(19930201)71:3+3.0.co;2-0.
PubMed 8428344Alcantara-Silva TR, Freitas-Junior R, Freitas NM, Machado GD. Fatigue related to radiotherapy for breast and/or gynaecological cancer: a systematic review. J Clin Nurs. 2013 Oct;22(19-20):2679-86. doi: 10.1111/jocn.12236. Epub 2013 May 8.
PubMed 23651041Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K. Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life. Ann Oncol. 2014 Nov;25(11):2237-2243. doi: 10.1093/annonc/mdu374. Epub 2014 Aug 5.
PubMed 25096607Dhruva A, Dodd M, Paul SM, Cooper BA, Lee K, West C, Aouizerat BE, Swift PS, Wara W, Miaskowski C. Trajectories of fatigue in patients with breast cancer before, during, and after radiation therapy. Cancer Nurs. 2010 May-Jun;33(3):201-12. doi: 10.1097/NCC.0b013e3181c75f2a.
PubMed 20357659Jereczek-Fossa BA, Marsiglia HR, Orecchia R. Radiotherapy-related fatigue. Crit Rev Oncol Hematol. 2002 Mar;41(3):317-25. doi: 10.1016/s1040-8428(01)00143-3.
PubMed 11880207Morrow GR, Shelke AR, Roscoe JA, Hickok JT, Mustian K. Management of cancer-related fatigue. Cancer Invest. 2005;23(3):229-39. doi: 10.1081/cnv-200055960.
PubMed 15945509Mustian KM, Peppone L, Darling TV, Palesh O, Heckler CE, Morrow GR. A 4-week home-based aerobic and resistance exercise program during radiation therapy: a pilot randomized clinical trial. J Support Oncol. 2009 Sep-Oct;7(5):158-67.
PubMed 19831159Noal S, Levy C, Hardouin A, Rieux C, Heutte N, Segura C, Collet F, Allouache D, Switsers O, Delcambre C, Delozier T, Henry-Amar M, Joly F. One-year longitudinal study of fatigue, cognitive functions, and quality of life after adjuvant radiotherapy for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):795-803. doi: 10.1016/j.ijrobp.2010.06.037. Epub 2010 Oct 1.
PubMed 20888704Hickok JT, Roscoe JA, Morrow GR, Mustian K, Okunieff P, Bole CW. Frequency, severity, clinical course, and correlates of fatigue in 372 patients during 5 weeks of radiotherapy for cancer. Cancer. 2005 Oct 15;104(8):1772-8. doi: 10.1002/cncr.21364.
PubMed 16116608Ryan JL, Carroll JK, Ryan EP, Mustian KM, Fiscella K, Morrow GR. Mechanisms of cancer-related fatigue. Oncologist. 2007;12 Suppl 1:22-34. doi: 10.1634/theoncologist.12-S1-22.
PubMed 17573453Bower JE, Ganz PA, Tao ML, Hu W, Belin TR, Sepah S, Cole S, Aziz N. Inflammatory biomarkers and fatigue during radiation therapy for breast and prostate cancer. Clin Cancer Res. 2009 Sep 1;15(17):5534-40. doi: 10.1158/1078-0432.CCR-08-2584. Epub 2009 Aug 25.
PubMed 19706826
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT02846389
- Acronym / sponsor ID
- Pro2016-0162
- Conditions
- Cancer Related Fatigue
- Keywords
- Radiation therapy for Breast Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Lombardi Comprehensive Cancer Center
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.
Detailed description
Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Exercise | Experimental | Other: Moderate ExerciseModerate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). |
| Control Group | No intervention | –No exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- women between the ages of 18 and 75 years
- histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
- radiation therapy naïve
- sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
- ambulatory
Key exclusion criteria (9 listed)
- younger than 18 or older than 75 years
- no histological confirmation of breast cancer
- prior breast, chest, or pelvic radiotherapy
- concurrent chemotherapy
- distant metastases
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 ExerciseAerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time. | Other | Moderate Exercise |
Primary outcome
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
Time frame: Baseline, 4 weeks into RT
The Functional Assessment of Chronic Illness Therapy (FACIT) is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point likert scale, with score ranging from 0 to 52 (52 being the total score allowed). The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reversed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
Time frame: Baseline, 4 weeks into RT
Serum hsCRP will be measured on the Vitros 5,1 FS Chemistry platform via an immunoassay with a reportable range of 0.10 -15.00 mg/L, and intra- and inter-assay CVs of 1.8-4.0%. Change is reported based on the difference in the group mean of Serum hsCRP level between baseline and T4 visit.
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
Time frame: Baseline, 4 weeks into RT
Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. Change is reported based on the difference in the group mean of Serum fibrinogen level between baseline and T4 visit.
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
Time frame: Baseline, 4 weeks into RT
Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. Change is reported based on the difference in the group mean of ferritin levels between baseline and T4 visit.
1 secondary outcome
Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.
Time frame: Baseline, 4 weeks into RT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23537231Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013 Mar 28;13:162. doi: 10.1186/1471-2407-13-162.
- Background: PubMed 12192016Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128.
- Background: PubMed 12128109Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2.
- Background: PubMed 9469327Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
- Background: PubMed 8428344Bagshaw MA, Kaplan ID, Cox RC. Prostate cancer. Radiation therapy for localized disease. Cancer. 1993 Feb 1;71(3 Suppl):939-52. doi: 10.1002/1097-0142(19930201)71:3+3.0.co;2-0.
- Background: PubMed 23651041Alcantara-Silva TR, Freitas-Junior R, Freitas NM, Machado GD. Fatigue related to radiotherapy for breast and/or gynaecological cancer: a systematic review. J Clin Nurs. 2013 Oct;22(19-20):2679-86. doi: 10.1111/jocn.12236. Epub 2013 May 8.
- Background: PubMed 25096607Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K. Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life. Ann Oncol. 2014 Nov;25(11):2237-2243. doi: 10.1093/annonc/mdu374. Epub 2014 Aug 5.
- Background: PubMed 20357659Dhruva A, Dodd M, Paul SM, Cooper BA, Lee K, West C, Aouizerat BE, Swift PS, Wara W, Miaskowski C. Trajectories of fatigue in patients with breast cancer before, during, and after radiation therapy. Cancer Nurs. 2010 May-Jun;33(3):201-12. doi: 10.1097/NCC.0b013e3181c75f2a.
- Background: PubMed 11880207Jereczek-Fossa BA, Marsiglia HR, Orecchia R. Radiotherapy-related fatigue. Crit Rev Oncol Hematol. 2002 Mar;41(3):317-25. doi: 10.1016/s1040-8428(01)00143-3.
- Background: PubMed 15945509Morrow GR, Shelke AR, Roscoe JA, Hickok JT, Mustian K. Management of cancer-related fatigue. Cancer Invest. 2005;23(3):229-39. doi: 10.1081/cnv-200055960.
- Background: PubMed 19831159Mustian KM, Peppone L, Darling TV, Palesh O, Heckler CE, Morrow GR. A 4-week home-based aerobic and resistance exercise program during radiation therapy: a pilot randomized clinical trial. J Support Oncol. 2009 Sep-Oct;7(5):158-67.
- Background: PubMed 20888704Noal S, Levy C, Hardouin A, Rieux C, Heutte N, Segura C, Collet F, Allouache D, Switsers O, Delcambre C, Delozier T, Henry-Amar M, Joly F. One-year longitudinal study of fatigue, cognitive functions, and quality of life after adjuvant radiotherapy for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):795-803. doi: 10.1016/j.ijrobp.2010.06.037. Epub 2010 Oct 1.
- Individual participant dataSharing planned: No
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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.
Brett Lewis, M.D., Ph.D principal investigator
Hackensack UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Exercise in people with Cancer Related Fatigue, run by Hackensack Meridian Health 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 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: stopped early, as of the sponsor's last update on 23 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument. (time frame: Baseline, 4 weeks into RT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846389, which also lists 34 linked publications.
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 23 Jul 2025.