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Supportive Care for Breast Cancer

N/A
Waitlist Available
Led By Meagan Whisenant
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months
Awards & highlights

Study Summary

This trial is testing an e-health support program to help newly diagnosed breast cancer patients with symptoms like pain, fatigue, depression, and anxiety. The goal is to improve overall health.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Impact of electronic (e)-health support program on patient reported outcomes

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601
67%
Hyponatremia
67%
Alanine aminotransferase increased
67%
Platelet count decreased
67%
Aspartate aminotransferase increased
67%
Anemia
50%
Hypermagnesemia
50%
Blood bilirubin increased
50%
Hypoalbuminemia
33%
Hypokalemia
33%
Hypophosphatemia
33%
Chest pain - cardiac
33%
Lymphocyte count decreased
33%
Sinusitis
33%
Hyperphosphatemia
33%
Hypocalcemia
33%
Blood bicarbonate decreased
17%
Anorexia
17%
Rhabdomyolysis
17%
Creatinine increased
17%
Hypernatremia
17%
Hypotension
17%
Dizziness
17%
Sinus tachycardia
17%
Diarrhea
17%
Hoarseness
17%
Retroperitoneal hemorrhage
17%
Abdominal pain
17%
Pain
17%
Duodenal ulcer
17%
Anxiety
17%
Hypoglycemia
17%
Constipation
17%
Nausea
17%
Esophagitis
17%
Metabolism and nutrition disorders - Other, specify:Mild protein-calorie malnutrition
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Run In
Control Group
Mesenchymal Stromal Cells (MSCs)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (Pack Health Program)Experimental Treatment2 Interventions
Patients participate in the Pack Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application and weekly interaction with a health coach over 3 months. They also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.
Group II: Group II (standard of care support services)Active Control2 Interventions
Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive Care
2013
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,095 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,945 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Meagan WhisenantPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
287 Total Patients Enrolled
~52 spots leftby May 2025
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