Trial Outcomes & Findings for Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes (NCT NCT04183218)

Last Updated: 2026-04-21

Results Overview

Assessed as any cardiac event after registration, including electrophysiological changes as defined by the continuous insertable cardiac monitor (ICM); congestive heart failure (CHF); myocardial infarction; pericarditis or myocarditis; cardiac ablation or cardiac pacemaker; cardiac stent placement or any coronary procedure for coronary damage; or any cardiac event as defined by the patients' medical records or autopsy if done.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2026-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Observational (Cardiac Monitoring) Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.\> \> Biospecimen Collection: Undergo biospecimen collection\> \> Cardiac Event Monitor: Receive cardiac monitor\> \> Chemoradiotherapy: Undergo CRT\> \> Radiation Therapy: Undergo RT
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational (Cardiac Monitoring) n=22 Participants Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.\> \> Biospecimen Collection: Undergo biospecimen collection\> \> Cardiac Event Monitor: Receive cardiac monitor\> \> Chemoradiotherapy: Undergo CRT\> \> Radiation Therapy: Undergo RT
Age, Continuous	67.046 years STANDARD_DEVIATION 9.511 • n=13 Participants
Sex: Female, Male Female	13 Participants n=13 Participants
Sex: Female, Male Male	9 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	1 Participants n=13 Participants
Race (NIH/OMB) White	20 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants
Recurrence Yes	0 Participants n=13 Participants
Recurrence No	22 Participants n=13 Participants
Prior Surgery Yes	12 Participants n=13 Participants
Prior Surgery No	10 Participants n=13 Participants
Prior Radiation Yes	1 Participants n=13 Participants
Prior Radiation No	21 Participants n=13 Participants
Prior Systemic Treatment Yes	5 Participants n=13 Participants
Prior Systemic Treatment No	17 Participants n=13 Participants
Smoking history Never	6 Participants n=13 Participants
Smoking history Previous	15 Participants n=13 Participants
Smoking history Current	1 Participants n=13 Participants
Smoking history Unknown	0 Participants n=13 Participants
Has the patient had any (other) prior cancer diagnosed? Yes	8 Participants n=13 Participants
Has the patient had any (other) prior cancer diagnosed? No	14 Participants n=13 Participants
Site of prior cancer Cervix	1 Participants n=13 Participants
Site of prior cancer Lung, Right upper lobe	1 Participants n=13 Participants
Site of prior cancer Melanoma, upper back (2019); BCC upper back (no date)	1 Participants n=13 Participants
Site of prior cancer Prostate	2 Participants n=13 Participants
Site of prior cancer Right Nare BCC	1 Participants n=13 Participants
Site of prior cancer Squamous cell carcinoma of the ear	1 Participants n=13 Participants
Site of prior cancer Thyroid cancer	1 Participants n=13 Participants
Site of prior cancer Missing	14 Participants n=13 Participants
Prior treatment regimen type Excision	2 Participants n=13 Participants
Prior treatment regimen type Hysterectomy	1 Participants n=13 Participants
Prior treatment regimen type Prostatectomy	1 Participants n=13 Participants
Prior treatment regimen type Prostatectomy; adjuvant radiation	1 Participants n=13 Participants
Prior treatment regimen type Thyroidectomy, I-131 therapy - 2005.	1 Participants n=13 Participants
Prior treatment regimen type Wedge excision	1 Participants n=13 Participants
Prior treatment regimen type unknown method of removal	1 Participants n=13 Participants
Prior treatment regimen type Missing	14 Participants n=13 Participants
Weight (kg)	86.514 kg STANDARD_DEVIATION 20.705 • n=13 Participants
Height (cm)	171.529 cm STANDARD_DEVIATION 9.983 • n=13 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Observational (Cardiac Monitoring) n=22 Participants Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months. \> \> Biospecimen Collection: Undergo biospecimen collection \> \> Cardiac Event Monitor: Receive cardiac monitor \> \> Chemoradiotherapy: Undergo CRT \> \> Radiation Therapy: Undergo RT
Proportion of Participants With a Cardiac Event at 12 Months	0.6818 proportion of participants Interval 0.4513 to 0.8614

SECONDARY outcome

Timeframe: Up to 12 months

Loco-regional recurrence is defined as local recurrences of the cancer in the\> same location where the disease was found on any diagnostic or\> staging study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Disease- free survival is defined as the time from study registration until any disease recurrence or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Distant recurrence is defined as metastatic cancer (cancer that has spread to organs or tissues far from the original cancer) that has either been biopsy\> confirmed or clinically diagnosed as recurrent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Cardiac event free survival is defined as the time from registration to any cardiac\> event or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Cardiac death is defined as the time from registration to death due to cardiac\> reasons. Cardiac death would include documented congestive heart failure, myocardial infarction, arrhythmia\*, heart block\*, or any other cardiac cause documented in the medical records, death certificate, or autopsy as one of the major contributing causes of death. \*Any lethal electrophysiologic change documented by before death would also be included.

Outcome measures

Outcome measures
Measure	Observational (Cardiac Monitoring) n=22 Participants Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months. \> \> Biospecimen Collection: Undergo biospecimen collection \> \> Cardiac Event Monitor: Receive cardiac monitor \> \> Chemoradiotherapy: Undergo CRT \> \> Radiation Therapy: Undergo RT
Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Overall survival is defined as the time from registration to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within the first 6 months from the date of enrollment

Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Outcome measures

Outcome measures
Measure	Observational (Cardiac Monitoring) n=22 Participants Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months. \> \> Biospecimen Collection: Undergo biospecimen collection \> \> Cardiac Event Monitor: Receive cardiac monitor \> \> Chemoradiotherapy: Undergo CRT \> \> Radiation Therapy: Undergo RT
Incidence of Acute 3+ Adverse Events (AE) Death NOS	3 adverse events
Incidence of Acute 3+ Adverse Events (AE) Dehydration	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Dysphagia	3 adverse events
Incidence of Acute 3+ Adverse Events (AE) Dyspnea	2 adverse events
Incidence of Acute 3+ Adverse Events (AE) Esophagitis	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Febrile neutropenia	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Respiratory failure	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Sepsis	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Gastric necrosis	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Disease progression	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Non-cardiac chest pain	1 adverse events
Incidence of Acute 3+ Adverse Events (AE) Gastric anastomotic leak	1 adverse events

SECONDARY outcome

Timeframe: After the first 6 months from the date of enrollment

Adverse Event incidence and severity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Cause specific survival is defined as the time from registration to death due to cancer.

Outcome measures

Outcome measures
Measure	Observational (Cardiac Monitoring) n=22 Participants Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months. \> \> Biospecimen Collection: Undergo biospecimen collection \> \> Cardiac Event Monitor: Receive cardiac monitor \> \> Chemoradiotherapy: Undergo CRT \> \> Radiation Therapy: Undergo RT
Cause Specific Survival	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 12 months

Imaging changes in the heart substructures associated with occurrence of cardiac events will be an exploratory component of this trial. Changes will be described at each time point using frequency distributions.

Outcome measures

Outcome data not reported

Adverse Events

Observational (Cardiac Monitoring)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Observational (Cardiac Monitoring) n=24 participants at risk Radiation Therapy: Undergo RT
General disorders Death NOS	12.5% 3/24 • Number of events 3 • Up to 12 months
General disorders Disease progression	4.2% 1/24 • Number of events 1 • Up to 12 months

Other adverse events

Other adverse events
Measure	Observational (Cardiac Monitoring) n=24 participants at risk Radiation Therapy: Undergo RT
Gastrointestinal disorders Gastric necrosis	4.2% 1/24 • Number of events 1 • Up to 12 months
Gastrointestinal disorders Nausea	37.5% 9/24 • Number of events 10 • Up to 12 months
Gastrointestinal disorders Vomiting	4.2% 1/24 • Number of events 1 • Up to 12 months
General disorders Fatigue	66.7% 16/24 • Number of events 26 • Up to 12 months
General disorders Non-cardiac chest pain	4.2% 1/24 • Number of events 2 • Up to 12 months
General disorders Pain	16.7% 4/24 • Number of events 6 • Up to 12 months
Infections and infestations Sepsis	4.2% 1/24 • Number of events 1 • Up to 12 months
Injury, poisoning and procedural complications Dermatitis radiation	37.5% 9/24 • Number of events 10 • Up to 12 months
Injury, poisoning and procedural complications Gastric anastomotic leak	4.2% 1/24 • Number of events 1 • Up to 12 months
Investigations Weight loss	8.3% 2/24 • Number of events 2 • Up to 12 months
Metabolism and nutrition disorders Anorexia	16.7% 4/24 • Number of events 6 • Up to 12 months
Metabolism and nutrition disorders Dehydration	4.2% 1/24 • Number of events 2 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Cough	37.5% 9/24 • Number of events 16 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Dyspnea	70.8% 17/24 • Number of events 58 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	4.2% 1/24 • Number of events 1 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.2% 1/24 • Number of events 1 • Up to 12 months
Blood and lymphatic system disorders Febrile neutropenia	4.2% 1/24 • Number of events 1 • Up to 12 months
Cardiac disorders Aortic valve disease	4.2% 1/24 • Number of events 1 • Up to 12 months
Cardiac disorders Chest pain - cardiac	4.2% 1/24 • Number of events 1 • Up to 12 months
Cardiac disorders Conduction disorder	70.8% 17/24 • Number of events 24 • Up to 12 months
Cardiac disorders Heart failure	8.3% 2/24 • Number of events 8 • Up to 12 months
Cardiac disorders Pericardial effusion	12.5% 3/24 • Number of events 5 • Up to 12 months
Gastrointestinal disorders Constipation	12.5% 3/24 • Number of events 5 • Up to 12 months
Gastrointestinal disorders Diarrhea	12.5% 3/24 • Number of events 4 • Up to 12 months
Gastrointestinal disorders Dysphagia	41.7% 10/24 • Number of events 17 • Up to 12 months
Gastrointestinal disorders Esophageal pain	12.5% 3/24 • Number of events 4 • Up to 12 months
Gastrointestinal disorders Esophagitis	29.2% 7/24 • Number of events 11 • Up to 12 months

Additional Information

Dr. Carlos E. Vargas

Mayo Clinic

Phone: 480-342-1262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place