EXCAP: Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

• Sponsor: Gary Morrow (Other)
• Overall Status: Completed
• CT.gov ID: NCT00924651
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 693
• Location: 1
• Arms: 2
• Duration (Months): 85
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief 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.

PURPOSE: This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Fatigue; Unspecified Adult Solid Tumor, Protocol Specific	Behavioral: exercise	N/A

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

• Study Type: Interventional
• Actual Enrollment: 693 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Study of the Effects of Exercise on Cancer-Related Fatigue
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Care + EXCAP Personalized exercise prescription	Behavioral: exercise; home based walking and progressive resistance training exercise; Other Names: EXCAP
No Intervention: Standard Care Wait list control

Outcome Measures

Primary Outcome Measures

1. 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) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• Gary Morrow
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Karen M. Mustian, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Gary Morrow, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT00924651
• Other Study ID Numbers: UCCO08106; URCC0701; U10CA037420; UCCO-08106; URCC 0701
• First Posted: Jun 19, 2009
• Last Update Posted: Aug 8, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gary Morrow, Professor, University of Rochester: fatigue; unspecified adult solid tumor, protocol specific
• Additional relevant MeSH terms: Fatigue

Study Results

Participant Flow

Arm/Group Title	Standard Care + EXCAP	Standard Care
Arm/Group Description	Personalized exercise prescription exercise: home based walking and progressive resistance training exercise	Wait list control
Period Title: Overall Study
STARTED	356	337
COMPLETED	331	312
NOT COMPLETED	25	25

Baseline Characteristics

Arm/Group Title	Standard Care + EXCAP	Standard Care	Total
Arm/Group Description	Personalized exercise prescription exercise: home based walking and progressive resistance training exercise	Wait list control	Total of all reporting groups
Overall Participants	331	312	643
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (11.9)	56.4 (10.1)	56.8 (11.1)
Sex: Female, Male (Count of Participants)
Female	306 92.4%	298 95.5%	604 93.9%
Male	25 7.6%	14 4.5%	39 6.1%
Race/Ethnicity, Customized (Count of Participants)
White	285 86.1%	265 84.9%	550 85.5%
Black	30 9.1%	30 9.6%	60 9.3%
Other	16 4.8%	17 5.4%	33 5.1%
Body Mass Index (BMI) (kg / m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg / m^2]	30.1 (6.7)	30.2 (6.4)	30.1 (6.5)
Currently Employed (Count of Participants)
Employed outside the house	184 55.6%	184 59%	368 57.2%
Self-Employed	11 3.3%	16 5.1%	27 4.2%
Home-Maker with >= 1 dependents	32 9.7%	23 7.4%	55 8.6%
Unemployed	104 31.4%	89 28.5%	193 30%
Marital Status (Count of Participants)
Married or long-term committed relationship	236 71.3%	214 68.6%	450 70%
Divorced or separated	24 7.3%	40 12.8%	64 10%
Single	44 13.3%	36 11.5%	80 12.4%
Widowed	27 8.2%	22 7.1%	49 7.6%
Education (Count of Participants)
Graduate degree	67 20.2%	46 14.7%	113 17.6%
2 or 4 degree or Some college	165 49.8%	165 52.9%	330 51.3%
High school / GED degree	88 26.6%	86 27.6%	174 27.1%
No high school or GED degree	10 3%	14 4.5%	24 3.7%
Unknown	1 0.3%	1 0.3%	2 0.3%
Cancer Type (Count of Participants)
Breast	271 81.9%	267 85.6%	538 83.7%
Lymphoma	17 5.1%	7 2.2%	24 3.7%
Colon	20 6%	15 4.8%	35 5.4%
Lung	6 1.8%	9 2.9%	15 2.3%
Other	17 5.1%	14 4.5%	31 4.8%
Cancer Stage (Count of Participants)
Stage I	80 24.2%	84 26.9%	164 25.5%
Stage II	150 45.3%	139 44.6%	289 44.9%
Stage III	84 25.4%	77 24.7%	161 25%
Stage IV	6 1.8%	5 1.6%	11 1.7%
Unknown	11 3.3%	7 2.2%	18 2.8%
Previous Treatment - Surgery (Count of Participants)
Yes	296 89.4%	275 88.1%	571 88.8%
No	35 10.6%	37 11.9%	72 11.2%
Previous Treatment - Chemotherapy (Count of Participants)
Yes	2 0.6%	4 1.3%	6 0.9%
No	329 99.4%	308 98.7%	637 99.1%
Previous Treatment - Radiation Therapy (Count of Participants)
Yes	8 2.4%	6 1.9%	14 2.2%
No	323 97.6%	306 98.1%	629 97.8%
Previous Treatment - Hormone Therapy (Count of Participants)
Yes	13 3.9%	8 2.6%	21 3.3%
No	318 96.1%	304 97.4%	622 96.7%
Time since end of first cancer treatment, weeks (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	14.5 (72.9)	6.8 (23.7)	10.8 (55.2)
Karnofsky Performance Status (KPS) (Karnofsky Performance Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Karnofsky Performance Scale]	94.2 (7.1)	94.8 (6.8)	94.5 (7.0)
Exercise Stages of Change (Count of Participants)
Not exercising and don't intend to in next 6 month	43 13%	36 11.5%	79 12.3%
Not exercising but do intend to in next 6 months	89 26.9%	83 26.6%	172 26.7%
Not exercising but intend to in next 30 days	199 60.1%	192 61.5%	391 60.8%
Exercising and have been for less than 6 months	0 0%	1 0.3%	1 0.2%
Exercising and have been for more than 6 months	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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).
Time Frame	41 days: Day 0 (before intervention) Day 41 (post intervention)

Outcome Measure Data

Analysis Population Description

Subjects completing both BFI at day 0 and day 41

Arm/Group Title	Standard Care + EXCAP	Standard Care
Arm/Group Description	Personalized exercise prescription exercise: home based walking and progressive resistance training exercise	Wait list control
Measure Participants	274	276
Mean (Standard Deviation) [units on a scale]	0.9 (2.4)	0.7 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care + EXCAP, Standard Care
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9148
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01916
	Confidence Interval	(2-Sided) 95%; -0.3710 to 0.3327
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1791
	Estimation Comments

Adverse Events

Arm/Group Title	Standard Care + EXCAP		Standard Care
Arm/Group Description	Personalized exercise prescription exercise: home based walking and progressive resistance training exercise		Wait list control
All Cause Mortality
	Standard Care + EXCAP		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care + EXCAP		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/331 (1.2%)		1/312 (0.3%)
Blood and lymphatic system disorders
Lymphopenia, gr 4 leukocytes & neutrophils	1/331 (0.3%)		0/312 (0%)
Neutropenia & possible port infection	1/331 (0.3%)		0/312 (0%)
Neutropenia	0/331 (0%)		1/312 (0.3%)
Neutropenia, cough, fever, fatigue	1/331 (0.3%)		0/312 (0%)
General disorders
Multi organ failure & susbsequent death	1/331 (0.3%)		0/312 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care + EXCAP		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/331 (0.6%)		3/312 (1%)
Blood and lymphatic system disorders
Febrile neutropenia	0/331 (0%)		1/312 (0.3%)
Neutropenic fever	0/331 (0%)		1/312 (0.3%)
Gastrointestinal disorders
Abdominal pain/acute typhilitis w/ neutropenia	0/331 (0%)		1/312 (0.3%)
General disorders
Failure to thrive (dehydra, hypokalemia, anorexia, diarrhea, fatigue	1/331 (0.3%)		0/312 (0%)
Vascular disorders
Questionable thrombosis/thrombus/embolism	1/331 (0.3%)		0/312 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.