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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| UCCO-08106 | Other Identifier | URCC | |
| URCC 0701 | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue.
PURPOSE: This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.
OBJECTIVES:
Primary
OUTLINE: This is a multicenter study. Patients are stratified according to participating site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 intervention arms.
Patients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales, Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care + EXCAP | Experimental | Personalized exercise prescription |
|
| Standard Care | No Intervention | Wait list control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral | home based walking and progressive resistance training exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention) | BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention). | 41 days: Day 0 (before intervention) Day 41 (post intervention) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen M. Mustian, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41825129 | Derived | Mustian KM, Lin PJ, Chakrabarti A, Mattick LJ, Samuel S, Gada U, Altman BJ, Vertino PM, Kleckner AS, Kleckner IR, Guido JJ, Li CS, Peppone LJ, Kamen CS, Loh KP, Rousey SR, Onitilo AA, Melnik M, Mohile SG, Janelsins MC. Effects of Exercise on Cognitive Impairment in Patients Receiving Chemotherapy: A Multicenter Phase III Randomized Controlled Trial. J Natl Compr Canc Netw. 2026 Mar;24(3):91-99. doi: 10.6004/jnccn.2025.7118. | |
| 34191201 | Derived |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care + EXCAP | Personalized exercise prescription exercise: home based walking and progressive resistance training exercise |
| FG001 | Standard Care | Wait list control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care + EXCAP | Personalized exercise prescription exercise: home based walking and progressive resistance training exercise |
| BG001 | Standard Care | Wait list control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention) | BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue). The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention). | Subjects completing both BFI at day 0 and day 41 | Posted | Mean | Standard Deviation | units on a scale | 41 days: Day 0 (before intervention) Day 41 (post intervention) |
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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 | Standard Care + EXCAP | Personalized exercise prescription exercise: home based walking and progressive resistance training exercise |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia, gr 4 leukocytes & neutrophils | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen M. Mustian, PhD, MPH, Associate Professor | University of Rochester Medical Center | 585-273-1796 | Karen_Mustian@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Kleckner IR, Jusko TA, Culakova E, Chung K, Kleckner AS, Asare M, Inglis JE, Loh KP, Peppone LJ, Miller J, Melnik M, Kasbari S, Ossip D, Mustian KM. Longitudinal study of inflammatory, behavioral, clinical, and psychosocial risk factors for chemotherapy-induced peripheral neuropathy. Breast Cancer Res Treat. 2021 Sep;189(2):521-532. doi: 10.1007/s10549-021-06304-6. Epub 2021 Jun 30. |
| 30937600 | Derived | Kleckner IR, Kamen C, Cole C, Fung C, Heckler CE, Guido JJ, Culakova E, Onitilo AA, Conlin A, Kuebler JP, Mohile S, Janelsins M, Mustian KM. Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial. Support Care Cancer. 2019 Dec;27(12):4615-4625. doi: 10.1007/s00520-019-04772-7. Epub 2019 Apr 2. |
| 29243164 | Derived | Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14. |
| Overwhelmed |
|
| Noncompliant |
|
| Medical |
|
| Changed Mind |
|
| Incomplete Form |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | Mean | Standard Deviation | kg / m^2 |
|
| Currently Employed | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Cancer Stage | Stage I.This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body. Stage II and III.These stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not other parts of the body. Stage IV.This stage means that the cancer has spread to other organs or parts of the body. It may also be called metastatic cancer. Unknown Stage. There is not enough information to determine stage. Stage I is best, Stage IV is worst. | Count of Participants | Participants |
|
| Previous Treatment - Surgery | Count of Participants | Participants |
|
| Previous Treatment - Chemotherapy | Count of Participants | Participants |
|
| Previous Treatment - Radiation Therapy | Count of Participants | Participants |
|
| Previous Treatment - Hormone Therapy | Count of Participants | Participants |
|
| Time since end of first cancer treatment, weeks | Mean | Standard Deviation | weeks |
|
| Karnofsky Performance Status (KPS) | Measure Description: The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10. | Mean | Standard Deviation | Karnofsky Performance Scale |
|
| Exercise Stages of Change | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Standard Care + EXCAP | Personalized exercise prescription exercise: home based walking and progressive resistance training exercise |
| OG001 | Standard Care | Wait list control |
|
|
|
| 4 |
| 331 |
| 2 |
| 331 |
| EG001 | Standard Care | Wait list control | 1 | 312 | 3 | 312 |
| Multi organ failure & susbsequent death | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenia & possible port infection | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenia, cough, fever, fatigue | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Failure to thrive (dehydra, hypokalemia, anorexia, diarrhea, fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Abdominal pain/acute typhilitis w/ neutropenia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Questionable thrombosis/thrombus/embolism | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neutropenic fever | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
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