Trial Outcomes & Findings for Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients (NCT NCT04106609)

NCT ID: NCT04106609

Last Updated: 2024-06-07

Results Overview

Total number of missed fractions, determined by electronic medical record

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 251 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-06-07

Participant Flow

Participant milestones

Measure	Exercise Group Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with ACSM exercise guidelines for cancer survivors. Total dose of exercise was one time weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise was performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity was progressed until the participant reached 45%. Strength training involved a full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at a minimum of 30% of the individual's 1RM, or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's RPE values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching of all major muscle groups for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Overall Study STARTED	129	122
Overall Study COMPLETED	123	120
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Baseline characteristics by cohort

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: The study intervention is a supervised, individualized exercise oncology program described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-profit organization providing exercise training to individuals with cancer (https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise programs and nutritional guidance to approximately 500 patients annually to help relieve side effects related to cancer treatment.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.	Total n=251 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 0.19 • n=5 Participants	57.1 years STANDARD_DEVIATION 0.15 • n=7 Participants	56.45 years STANDARD_DEVIATION 0.18 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	122 Participants n=7 Participants	251 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	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	108 Participants n=7 Participants	216 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	10 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	11 Participants n=5 Participants	9 Participants n=7 Participants	20 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	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants	78 Participants n=7 Participants	158 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	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
BMI	28.74 kg/m2 STANDARD_DEVIATION 0.68 • n=5 Participants	30.24 kg/m2 STANDARD_DEVIATION 0.56 • n=7 Participants	29.48 kg/m2 STANDARD_DEVIATION 0.62 • n=5 Participants
Time Since Diagnosis	1.2 months STANDARD_DEVIATION 0.88 • n=5 Participants	2.1 months STANDARD_DEVIATION 0.82 • n=7 Participants	1.65 months STANDARD_DEVIATION 0.85 • n=5 Participants
Stage I Breast Cancer	53 participants n=5 Participants	51 participants n=7 Participants	104 participants n=5 Participants
Stage II Breast Cancer	76 participants n=5 Participants	71 participants n=7 Participants	147 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: This data was not collected from the medical record. Study personnel could not determine this from the medical record.

Total number of missed fractions, determined by electronic medical record

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: This data was not collected from the medical record. Study personnel could not determine from the medical record.

Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Medical expenditure and utilization, for each time a patient utilized an emergency room visit for the purpose of managing health problems in addition to the planned cancer care, determined by electronic medical record.

Outcome measures

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Cost of Emergency Room Visits	661 Dollars ($) Standard Error 210	989 Dollars ($) Standard Error 241

PRIMARY outcome

Timeframe: 12 weeks

Number of inpatient and outpatient hospital encounters, determined by electronic medical record

Outcome measures

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Encounters	7 total number of encounters Standard Error 7	12 total number of encounters Standard Error 6

PRIMARY outcome

Timeframe: 12 weeks

Population: "0" participants were analyzed because study personnel could not determine this from the electronic medical record.

Number of hospital readmissions for the same presenting issue, determined by electronic medical record

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: "0" participants were analyzed because study personnel could not determine this from the EMR

Hospital length of stay, in days, if applicable. Determined by electronic medical record.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record.

Percentage of patient adherence to their cancer treatment, determined by electronic medical record

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record.

Number of the different types of medications taken by patients for symptom management during their cancer treatment. Determined by electronic medical record.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record.

Total number of cancer treatment related side effects

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment.

The Short Form-36 survey was used to measure pain. A high score defines a more favorable health state. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores being 0 and 100, respectively.

Outcome measures

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Patient Rated Pain Score At baseline	50.4 score on a scale Standard Deviation 3.1	50.5 score on a scale Standard Deviation 3.16
Patient Rated Pain Score At Follow-up (after 12 weeks of exercise training)	62.3 score on a scale Standard Deviation 3.3	49.7 score on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: 12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.

Population: Note that at baseline, there were 129 people in the control group (CG) and 122 people in the exercise group (EX). At follow up, there were 120 people in CG and 123 people in EX.

Measured by the Eastern Cooperative Oncology Group (ECOG) performance status score. Scale is from 0 to 5, with 0 being high functioning and no restriction and 5 being dead.

Outcome measures

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Cancer TreatmentTtolerance Stage II Score 0-1 Follow-up	36 participants	21 participants
Cancer TreatmentTtolerance Stage I Score 0-1 Baseline	57 participants	51 participants
Cancer TreatmentTtolerance Stage I Score 2 Baseline	15 participants	14 participants
Cancer TreatmentTtolerance Stage I Score 0-1 Follow-up	46 participants	45 participants
Cancer TreatmentTtolerance Stage I Score 2 Follow-up	17 participants	21 participants
Cancer TreatmentTtolerance Stage II Score 0-1 Baseline	39 participants	36 participants
Cancer TreatmentTtolerance Stage II Score 2 Baseline	18 participants	21 participants
Cancer TreatmentTtolerance Stage II Score 2 Follow-up	24 participants	33 participants

PRIMARY outcome

Timeframe: Baseline was at the time of enrollment and follow up was after 12-weeks.

McGill Quality of Life Survey:

Physical Wellbeing (questions 1-4) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad.

Social Wellbeing (questions 12, 14-16) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad.

Emotional Wellbeing(questions 5-7, 13) - minimum score is 0 and maximum score is 40. A higher score would be bad and a lower score would be good Functional wellbeing (questions 8-11) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad.

FACT-BREAST Survey:

Minimum score is 0 and maximum is 148; 0 is not at all and 4 is very much, "good" or "bad" varies depending on the question; overall a higher score is good and a lower score is bad

Outcome measures

Measure	Exercise Group n=123 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=120 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Functional Well-Being at Baseline	19.8 score on a scale Standard Error 1.5	19.9 score on a scale Standard Error 1.6
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Physical Well-Being at Baseline	19.1 score on a scale Standard Error 1.7	19.2 score on a scale Standard Error 1.8
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Physical Well-Being Post-Intervention	23.1 score on a scale Standard Error 1.6	19.2 score on a scale Standard Error 1.9
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Social Well-Being at Baseline	19.6 score on a scale Standard Error 1.6	19.5 score on a scale Standard Error 1.7
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Social Well-Being Post-Intervention	23.1 score on a scale Standard Error 1.6	19.3 score on a scale Standard Error 1.6
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Emotional Well-Being at Baseline	18.7 score on a scale Standard Error 1.5	18.7 score on a scale Standard Error 1.4
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Emotional Well-Being Post-Intervention	20.2 score on a scale Standard Error 1.7	18.6 score on a scale Standard Error 1.2
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire Functional Well-Being Post-Intervention	23.2 score on a scale Standard Error 1.5	19.8 score on a scale Standard Error 1.7
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire FACT-Breast at Baseline	98.2 score on a scale Standard Error 3.4	98.3 score on a scale Standard Error 3.5
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire FACT-Breast Post-Intervention	114.2 score on a scale Standard Error 3.7	96.7 score on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: 12 weeks

Population: Because the control group did not participate in the exercise program, we did not calculate an adherence rate for this group.

Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records. Exercise session adherence rate was measured by dividing the total number of sessions scheduled by the total number of exercise sessions actually attended by the exercise group.

Outcome measures

Measure	Exercise Group n=1548 exercise sessions Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Adherence Rate	95 percentage of session	—

SECONDARY outcome

Timeframe: 12 weeks

Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records. Attrition was determined by calculating the percent of participants who completed the study by the total number of participants who started the study.

Outcome measures

Measure	Exercise Group n=129 Participants Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. Total dose of exercise was once weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity progressed until the participant reached 45%. Strength training involved full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at minimum of 30% of the individual's 1 Repetition Maximum1(RM), or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's Rating of Perceived Exertion (RPE) values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes.	Control Group n=122 Participants The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. Current standard of care: Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
Percentage of Participants Who Completed the Study (Attrition Rate)	95.3 percentage of participants	98.3 percentage of participants

Adverse Events

Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Wonders

Maple Tree Cancer Alliance

Phone: 937-477-8213

Email: karen.wonders@mapletreecanceralliance.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place