Trial Outcomes & Findings for Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer (NCT NCT02846389)
NCT ID: NCT02846389
Last Updated: 2025-07-23
Results Overview
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.
TERMINATED
NA
24 participants
Baseline, 4 weeks into RT
2025-07-23
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
No exercise
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
No exercise
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
Baseline characteristics by cohort
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
51 years
n=7 Participants
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks into RTThe 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.
Outcome measures
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
|---|---|---|
|
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
Baseline
|
17 FACIT Score
Standard Deviation 11
|
14 FACIT Score
Standard Deviation 8
|
|
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
4 weeks into RT
|
21 FACIT Score
Standard Deviation 9
|
18 FACIT Score
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks into RTSerum 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.
Outcome measures
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
|---|---|---|
|
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
Baseline
|
0.39 milligrams per liter (mg/L)
Standard Deviation 0.47
|
0.29 milligrams per liter (mg/L)
Standard Deviation 0.33
|
|
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
4 weeks into RT
|
0.21 milligrams per liter (mg/L)
Standard Deviation 0.19
|
0.13 milligrams per liter (mg/L)
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks into RTFibrinogen 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.
Outcome measures
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
|---|---|---|
|
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
Baseline
|
326 milligrams per deciliter (mg/dL)
Standard Deviation 69
|
307 milligrams per deciliter (mg/dL)
Standard Deviation 116
|
|
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
4 weeks into RT
|
288 milligrams per deciliter (mg/dL)
Standard Deviation 78
|
296 milligrams per deciliter (mg/dL)
Standard Deviation 77
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks into RTFerritin 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.
Outcome measures
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
|---|---|---|
|
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
Baseline
|
0.009 Micrograms per liter (mcg/L)
Standard Deviation 0.005
|
0.005 Micrograms per liter (mcg/L)
Standard Deviation 0.006
|
|
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
4 weeks into RT
|
0.008 Micrograms per liter (mcg/L)
Standard Deviation 0.003
|
0.006 Micrograms per liter (mcg/L)
Standard Deviation 0.004
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks into RTThe 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.
Outcome measures
| Measure |
Moderate Exercise
n=11 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.
|
Control Group
n=13 Participants
No exercise
|
|---|---|---|
|
Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.
Baseline
|
70 units on a scale
Standard Deviation 8
|
69 units on a scale
Standard Deviation 8
|
|
Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.
4 weeks into RT
|
66 units on a scale
Standard Deviation 11
|
71 units on a scale
Standard Deviation 10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4 weeks into RT, 4 week follow up visitWe will collect CBC data at each blood draw for correlative and explorative purposes.
Outcome measures
Outcome data not reported
Adverse Events
Moderate Exercise
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place