Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02846389

Enrollment

Registered

2016-07-27

Start date

2016-06-21

Completion date

2017-12-03

Last updated

2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Related Fatigue

Keywords

Radiation therapy for Breast Cancer

Brief summary

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.

Detailed description

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.

Interventions

OTHERModerate 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. women between the ages of 18 and 75 years 2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive) 3. radiation therapy naïve 4. sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire 5. ambulatory 6. negative serum pregnancy test and not planning to become pregnant in the next three months 7. able to provide meaningful consent. 8. Patients must have been deemed by their medical oncologist or internist that they may participate in \[this\] exercise trial. Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.

Exclusion criteria

1. younger than 18 or older than 75 years 2. no histological confirmation of breast cancer 3. prior breast, chest, or pelvic radiotherapy 4. concurrent chemotherapy 5. distant metastases 6. physical limitations that contraindicate participation in low to moderate intensity exercise 7. positive pregnancy test 8. currently engaged in moderate to vigorous physical activity 9. psychiatric disorder which would render the participant unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.	Baseline, 4 weeks into RT	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.
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)	Baseline, 4 weeks into RT	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.
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen	Baseline, 4 weeks into RT	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.
Assessment of Change in Blood Biomarker of Inflammation: Ferritin	Baseline, 4 weeks into RT	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.

Secondary

Measure	Time frame	Description
Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.	Baseline, 4 weeks into RT	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.

Other

Measure	Time frame	Description
Complete Blood Count Data (CBC)	Baseline, 4 weeks into RT, 4 week follow up visit	We will collect CBC data at each blood draw for correlative and explorative purposes.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	11
Control Group No exercise	13
Total	24

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Control Group	Total	Moderate Exercise
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	4 Participants	1 Participants
Age, Categorical Between 18 and 65 years	10 Participants	20 Participants	10 Participants
Age, Continuous	51 years	53.5 years	54 years
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	6 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants	17 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	12 Participants	23 Participants	11 Participants
Region of Enrollment United States	13 Participants	24 Participants	11 Participants
Sex: Female, Male Female	13 Participants	24 Participants	11 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 13
other Total, other adverse events	0 / 11	0 / 13
serious Total, serious adverse events	0 / 11	0 / 13

Outcome results

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.