FatigueEXCAPNCT00924651
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
A study testing exercise in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Gary Morrow at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- 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
- 693 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2016
- 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 21 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of cancer other than leukemia, with no distant metastasis
- chemotherapy naïve
- starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable
- Karnofsky Performance level of 70 or greater
- able to read English
Who cannot join
- diagnosis of leukemia
- metastatic disease
- receiving concurrent radiation therapy
- physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program
- identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Study of the Effects of Exercise on Cancer-Related Fatigue
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.
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.
- Arm I: Patients receive standard chemotherapy.
- Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy.
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.
- Being tested
- exercise
- Keywords
- fatigue, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called EXCAP
home based walking and progressive resistance training exercise
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + EXCAP | Experimental | Personalized exercise prescription Receives: Behavioral: exercise |
| Standard Care | No intervention | Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 41 days: Day 0 (before intervention) Day 41 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2016
- Study completionOct 2016
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 (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Morrow
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gary Morrow, University of Rochester
- Investigators
- Karen M. Mustian, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924651
- Sponsor's protocol ID
- UCCO08106; URCC0701
- Other IDs
- U10CA037420, UCCO-08106, URCC 0701
- Acronym
- EXCAP
- Status last verified
- Jul 2017
- First submitted
- 18 Jun 2009
- Last updated
- 8 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41825129Kleckner 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.
PubMed 34191201Kleckner 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.
PubMed 30937600Kleckner 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.
PubMed 29243164
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of Exercise on Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT00924651
- Acronym / sponsor ID
- EXCAP / UCCO08106; URCC0701
- Keywords
- fatigue, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Gary MorrowUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 8 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.
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.
- Arm I: Patients receive standard chemotherapy.
- Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care + EXCAP | Experimental | Behavioral: exercisePersonalized exercise prescription |
| Standard Care | No intervention | –Wait list control |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary diagnosis of cancer other than leukemia, with no distant metastasis
- chemotherapy naïve
- starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable
- Karnofsky Performance level of 70 or greater
- able to read English
Key exclusion criteria (5 listed)
- diagnosis of leukemia
- metastatic disease
- receiving concurrent radiation therapy
- physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program
- identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form
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 |
|---|---|---|
| exerciseAlso: EXCAPhome based walking and progressive resistance training exercise | Behavioural | Standard Care + EXCAP |
Primary outcome
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)
Time frame: 41 days: Day 0 (before intervention) Day 41 (post 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41825129Mustian 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.
- Derived from this study: PubMed 34191201Kleckner 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.
- Derived from this study: PubMed 30937600Kleckner 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.
- Derived from this study: PubMed 29243164Kleckner 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.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
- 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.
Karen M. Mustian, PhD principal investigator
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 and Unspecified Adult Solid Tumor, Protocol Specific, run by Gary Morrow 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 5 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 8 Aug 2017. 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 8 Aug 2017). 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?
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) (time frame: 41 days: Day 0 (before intervention) Day 41 (post intervention)). 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 NCT00924651, which also lists 4 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 8 Aug 2017.