Study Summary
This trial is comparing an exercise and protein intervention against a health education program to see if it helps older women better adhere to their breast cancer chemo schedules.
Eligible Conditions
- Breast Cancer
- Breast Cancer, Stage III
- Breast Cancer, Stage II
Treatment Effectiveness
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: Baseline to 26 weeks
Baseline to 26 weeks
Accelerometry
Anthropometric measure - height
Anthropometric measure - waist circumference
Anthropometric measure - weight
Diet
MOS SF-36 Questionnaire
Measure of hematologic chemotoxicity - Hematocrit
Hematologic Tests
Measure of hematologic chemotoxicity - Platelet count
Measure of hematologic chemotoxicity- White blood cell count
Morgenstern Physical Activity Questionnaire (PAQ-M)
Patient-reported chemotoxicities
Pittsburgh Sleep Quality Index (PSQI)
Received Dose Intensity (RDI)
Strength
Trial Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
HEALTH EDUCATION AND SUPPORT CONTROL GROUP
1 of 2
THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
1 of 2
Active Control
Experimental Treatment
270 Total Participants · 2 Treatment Groups
Primary Treatment: THRIVE · No Placebo Group · N/A
THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
Behavioral
Experimental Group · 1 Intervention: THRIVE · Intervention Types: BehavioralHEALTH EDUCATION AND SUPPORT CONTROL GROUP
Behavioral
ActiveComparator Group · 1 Intervention: Health Education Support Program · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THRIVE
2017
N/A
~350
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 26 weeks
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,279 Previous Clinical Trials
41,234,588 Total Patients Enrolled
931 Trials studying Breast Cancer
1,541,676 Patients Enrolled for Breast Cancer
Case Western Reserve UniversityOTHER
281 Previous Clinical Trials
198,939 Total Patients Enrolled
1 Trials studying Breast Cancer
8,400 Patients Enrolled for Breast Cancer
University of PittsburghOTHER
1,647 Previous Clinical Trials
16,311,379 Total Patients Enrolled
15 Trials studying Breast Cancer
3,079 Patients Enrolled for Breast Cancer
Penn State UniversityOTHER
333 Previous Clinical Trials
120,961 Total Patients Enrolled
1 Trials studying Breast Cancer
3 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,029 Previous Clinical Trials
755,565 Total Patients Enrolled
136 Trials studying Breast Cancer
21,421 Patients Enrolled for Breast Cancer
Nathan Berger, MDPrincipal InvestigatorCase Western Reserve University/University Hospitals Cleveland
1 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Breast Cancer
19 Patients Enrolled for Breast Cancer
Kathryn Schmitz (contact), PhD, MPHPrincipal InvestigatorUniversity of Pittsburgh
Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
8 Previous Clinical Trials
3,650 Total Patients Enrolled
6 Trials studying Breast Cancer
413 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 65+ · Female Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) is between 18 to 50.
You can walk for 6 minutes or 2 blocks, either with or without assistance.
Frequently Asked Questions
Are there any participants yet enrolled in this experiment?
"As per clinicaltrials.gov, this investigation is no longer recruited participants - the trial was originally posted on January 1st 2023 and updated lastly on November 28th 2022. However, there are presently 2614 other medical trials actively searching for patients to enroll in research." - Anonymous Online Contributor
Unverified Answer