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| Name | Class |
|---|---|
| Lombardi Comprehensive Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Exercise | Experimental | Moderate 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Blood Count Data (CBC) | We will collect CBC data at each blood draw for correlative and explorative purposes. | Baseline, 4 weeks into RT, 4 week follow up visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Lewis, M.D., Ph.D | Hackensack UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23537231 | Background | 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. | |
| 12192016 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Exercise | Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). Moderate Exercise: 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. |
| FG001 | Control Group | No exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Exercise | Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). Moderate Exercise: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | FACIT Score | Baseline, 4 weeks into RT |
|
Adverse Event Assessment performed through 4-week follow-up visit, an average of 14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Exercise | Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). Moderate Exercise: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Zenreich | Hackensack Meridian Health | 15519964248 | joshua.zenreich@hmhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2016 | Jun 16, 2023 | Prot_SAP_000.pdf |
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|
| Baseline, 4 weeks into RT |
| Baseline, 4 weeks into RT |
| Background |
| Fisher 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. |
| 12128109 | Background | Zelefsky 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. |
| 9469327 | Background | Fisher 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. |
| 8428344 | Background | Bagshaw 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. |
| 23651041 | Background | Alcantara-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. |
| 25096607 | Background | Steindorf 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. |
| 20357659 | Background | Dhruva 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. |
| 11880207 | Background | Jereczek-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. |
| 15945509 | Background | Morrow 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. |
| 19831159 | Background | Mustian 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. |
| 20888704 | Background | Noal 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. |
| 16116608 | Background | Hickok 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. |
| 17573453 | Background | Ryan 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. |
| 19706826 | Background | Bower 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. |
| 11597810 | Background | Geinitz H, Zimmermann FB, Stoll P, Thamm R, Kaffenberger W, Ansorg K, Keller M, Busch R, van Beuningen D, Molls M. Fatigue, serum cytokine levels, and blood cell counts during radiotherapy of patients with breast cancer. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):691-8. doi: 10.1016/s0360-3016(01)01657-1. |
| 18791747 | Background | Lundh Hagelin C, Wengstrom Y, Furst CJ. Patterns of fatigue related to advanced disease and radiotherapy in patients with cancer-a comparative cross-sectional study of fatigue intensity and characteristics. Support Care Cancer. 2009 May;17(5):519-26. doi: 10.1007/s00520-008-0502-5. Epub 2008 Sep 13. |
| 11072170 | Background | Hovdenak N, Fajardo LF, Hauer-Jensen M. Acute radiation proctitis: a sequential clinicopathologic study during pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2000 Nov 1;48(4):1111-7. doi: 10.1016/s0360-3016(00)00744-6. |
| 17562440 | Background | Larsen A, Bjorge B, Klementsen B, Helgeland L, Wentzel-Larsen T, Fagerhol MK, Hovdenak N, Dahl O. Time patterns of changes in biomarkers, symptoms and histopathology during pelvic radiotherapy. Acta Oncol. 2007;46(5):639-50. doi: 10.1080/02841860601099241. |
| 20005457 | Background | Symon Z, Goldshmidt Y, Picard O, Yavzori M, Ben-Horin S, Alezra D, Barshack I, Chowers Y. A murine model for the study of molecular pathogenesis of radiation proctitis. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):242-50. doi: 10.1016/j.ijrobp.2009.07.1736. |
| 7963760 | Background | Greenberg DB, Gray JL, Mannix CM, Eisenthal S, Carey M. Treatment-related fatigue and serum interleukin-1 levels in patients during external beam irradiation for prostate cancer. J Pain Symptom Manage. 1993 May;8(4):196-200. doi: 10.1016/0885-3924(93)90127-h. |
| 17393200 | Background | Christiansen H, Saile B, Hermann RM, Rave-Frank M, Hille A, Schmidberger H, Hess CF, Ramadori G. Increase of hepcidin plasma and urine levels is associated with acute proctitis and changes in hemoglobin levels in primary radiotherapy for prostate cancer. J Cancer Res Clin Oncol. 2007 May;133(5):297-304. doi: 10.1007/s00432-006-0170-0. Epub 2006 Nov 25. |
| 22595751 | Background | Saligan LN, Kim HS. A systematic review of the association between immunogenomic markers and cancer-related fatigue. Brain Behav Immun. 2012 Aug;26(6):830-48. doi: 10.1016/j.bbi.2012.05.004. Epub 2012 May 14. |
| 12721239 | Background | Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093. |
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| 8404803 | Background | King AC, Taylor CB, Haskell WL. Effects of differing intensities and formats of 12 months of exercise training on psychological outcomes in older adults. Health Psychol. 1993 Jul;12(4):292-300. doi: 10.1037//0278-6133.12.4.292. |
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| 9008666 | Background | Singh NA, Clements KM, Fiatarone MA. A randomized controlled trial of progressive resistance training in depressed elders. J Gerontol A Biol Sci Med Sci. 1997 Jan;52(1):M27-35. doi: 10.1093/gerona/52a.1.m27. |
| 2587289 | Background | MacVicar MG, Winningham ML, Nickel JL. Effects of aerobic interval training on cancer patients' functional capacity. Nurs Res. 1989 Nov-Dec;38(6):348-51. |
| 15484202 | Background | Mock V, Frangakis C, Davidson NE, Ropka ME, Pickett M, Poniatowski B, Stewart KJ, Cameron L, Zawacki K, Podewils LJ, Cohen G, McCorkle R. Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. Psychooncology. 2005 Jun;14(6):464-77. doi: 10.1002/pon.863. |
| 17964881 | Background | Monga U, Garber SL, Thornby J, Vallbona C, Kerrigan AJ, Monga TN, Zimmermann KP. Exercise prevents fatigue and improves quality of life in prostate cancer patients undergoing radiotherapy. Arch Phys Med Rehabil. 2007 Nov;88(11):1416-22. doi: 10.1016/j.apmr.2007.08.110. |
| BG001 | Control Group | No exercise |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). Moderate Exercise: 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. |
| OG001 | Control Group | No exercise |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | Baseline, 4 weeks into RT |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, 4 weeks into RT |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Micrograms per liter (mcg/L) | Baseline, 4 weeks into RT |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks into RT |
|
|
|
| Other Pre-specified | Complete Blood Count Data (CBC) | We will collect CBC data at each blood draw for correlative and explorative purposes. | Not Posted | Baseline, 4 weeks into RT, 4 week follow up visit | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control Group | No exercise | 0 | 13 | 0 | 13 | 0 | 13 |
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