Trial Outcomes & Findings for Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer (NCT NCT03345420)
NCT ID: NCT03345420
Last Updated: 2025-12-30
Results Overview
The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Up to 24 months post radiation therapy (RT)
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Treatment
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
Hypofractionated Radiotherapy
|
102
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Of 102 total enrolled participants, images from 89 participants at baseline were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
Baseline characteristics by cohort
| Measure |
Treatment
n=102 Participants
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=102 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=102 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=102 Participants
|
|
Age, Continuous
|
58.71 years
STANDARD_DEVIATION 10.72 • n=102 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=102 Participants
|
|
Breast photographic cosmetic scores
Excellent
|
36 Participants
n=89 Participants • Of 102 total enrolled participants, images from 89 participants at baseline were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
|
|
Breast photographic cosmetic scores
Good
|
32 Participants
n=89 Participants • Of 102 total enrolled participants, images from 89 participants at baseline were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
|
|
Breast photographic cosmetic scores
Fair
|
19 Participants
n=89 Participants • Of 102 total enrolled participants, images from 89 participants at baseline were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
|
|
Breast photographic cosmetic scores
Poor
|
2 Participants
n=89 Participants • Of 102 total enrolled participants, images from 89 participants at baseline were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
|
PRIMARY outcome
Timeframe: Up to 24 months post radiation therapy (RT)Population: Of 102 total enrolled participants, images from 78 participants at this timepoint were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers.
Outcome measures
| Measure |
Treatment
n=78 Participants
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Excellent
|
17 Participants
|
|
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Good
|
26 Participants
|
|
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Fair
|
24 Participants
|
|
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Poor
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 months post RTPopulation: * 80 sexual well-being subscale questionnaires were completed at this timepoint * 95 satisfaction with breasts subscale questionnaires were completed at this timepoint
* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Outcome measures
| Measure |
Treatment
n=96 Participants
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
Physical well-being
|
68.2 score on a scale
Standard Deviation 22.9
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
Psychosocial well-being
|
79.6 score on a scale
Standard Deviation 20.2
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
Sexual well-being
|
63.4 score on a scale
Standard Deviation 26.1
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
Satisfaction with breasts
|
69 score on a scale
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: 24 months post RTPopulation: -80 sexual well-being subscale questionnaires were completed at this timepoint
* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Outcome measures
| Measure |
Treatment
n=90 Participants
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
Physical well-being
|
77.9 score on a scale
Standard Deviation 23.1
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
Psychosocial well-being
|
79.6 score on a scale
Standard Deviation 22.4
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
Sexual well-being
|
63 score on a scale
Standard Deviation 28.2
|
|
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
Satisfaction with breasts
|
68.8 score on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsWe will report the incidence of recurrence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsWill be explored using cost data and quality adjusted life years (QALYs)
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 4 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=102 participants at risk
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphasia
|
0.98%
1/102 • Number of events 2 • 3 years
|
|
Immune system disorders
Myasthenia Gravis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Breast infection
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.98%
1/102 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Treatment
n=102 participants at risk
Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
|
|---|---|
|
Reproductive system and breast disorders
Breast pain
|
63.7%
65/102 • Number of events 80 • 3 years
|
|
Reproductive system and breast disorders
Genital edema
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
25.5%
26/102 • Number of events 31 • 3 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.9%
5/102 • Number of events 6 • 3 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
8/102 • Number of events 8 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
12/102 • Number of events 12 • 3 years
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.8%
10/102 • Number of events 10 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
19/102 • Number of events 21 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
18.6%
19/102 • Number of events 20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
63.7%
65/102 • Number of events 67 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Social circumstances
Menopause
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
9.8%
10/102 • Number of events 15 • 3 years
|
|
Vascular disorders
Flushing
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Vascular disorders
Hematoma
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Vascular disorders
Hot flashes
|
38.2%
39/102 • Number of events 44 • 3 years
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Vascular disorders
Lymphedema
|
5.9%
6/102 • Number of events 6 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Nervous system disorders
Headache
|
13.7%
14/102 • Number of events 17 • 3 years
|
|
Nervous system disorders
Hypersomnia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Nervous system disorders
Memory impairment
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Nervous system disorders
Neuralgia
|
0.98%
1/102 • Number of events 2 • 3 years
|
|
Nervous system disorders
Paresthesia
|
5.9%
6/102 • Number of events 6 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Nervous system disorders
Tremor
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Psychiatric disorders
Agitation
|
5.9%
6/102 • Number of events 6 • 3 years
|
|
Psychiatric disorders
Anxiety
|
4.9%
5/102 • Number of events 6 • 3 years
|
|
Psychiatric disorders
Depression
|
7.8%
8/102 • Number of events 9 • 3 years
|
|
Psychiatric disorders
Insomnia
|
11.8%
12/102 • Number of events 13 • 3 years
|
|
Psychiatric disorders
Personality change
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.0%
2/102 • Number of events 3 • 3 years
|
|
Psychiatric disorders
Restlessness
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
General disorders
Fever
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Flu like symptoms
|
2.9%
3/102 • Number of events 5 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Irritability
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Localized edema
|
13.7%
14/102 • Number of events 17 • 3 years
|
|
General disorders
Malaise
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Pain
|
13.7%
14/102 • Number of events 16 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Immune system disorders
Allergic reaction
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Immune system disorders
Autoimmune disorder
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Infections and infestations
Bladder infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Breast infection
|
0.98%
1/102 • Number of events 9 • 3 years
|
|
Infections and infestations
Bronchial infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Esophageal infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Eye infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Gum infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Infections and infestations
Nail infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Infections and infestations
Otitis media
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Infections and infestations
Sinusitis
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Infections and infestations
Skin infection
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
11.8%
12/102 • Number of events 12 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
8.8%
9/102 • Number of events 11 • 3 years
|
|
Infections and infestations
Vaginal infection
|
3.9%
4/102 • Number of events 5 • 3 years
|
|
Infections and infestations
Wound infection
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
88.2%
90/102 • Number of events 111 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.8%
8/102 • Number of events 10 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
9.8%
10/102 • Number of events 10 • 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Seroma
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Investigations
Weight gain
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Investigations
Weight loss
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Investigations
White blood cell decreased
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
18/102 • Number of events 19 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
10/102 • Number of events 10 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.8%
11/102 • Number of events 12 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
11.8%
12/102 • Number of events 13 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.98%
1/102 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
21.6%
22/102 • Number of events 26 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
5/102 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
5/102 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.9%
6/102 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.5%
28/102 • Number of events 30 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
26.5%
27/102 • Number of events 27 • 3 years
|
|
Renal and urinary disorders
Urine discoloration
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Breast atrophy
|
6.9%
7/102 • Number of events 7 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
17/102 • Number of events 18 • 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Nervous system disorders
Concentration impairment
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
8.8%
9/102 • Number of events 9 • 3 years
|
|
Nervous system disorders
Dysesthesia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/102 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.9%
4/102 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Cardiac disorders
Palpitations
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Eye disorders
Blurred vision
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Eye disorders
Cataract
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Eye disorders
Dry eye
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.9%
3/102 • Number of events 4 • 3 years
|
|
Eye disorders
Eye pain
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Eye disorders
Watering eyes
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
8/102 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
9.8%
10/102 • Number of events 11 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.8%
11/102 • Number of events 11 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.98%
1/102 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.9%
7/102 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
19.6%
20/102 • Number of events 23 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.98%
1/102 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
6/102 • Number of events 7 • 3 years
|
|
General disorders
Chills
|
2.0%
2/102 • Number of events 2 • 3 years
|
|
General disorders
Edema limbs
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Edema trunk
|
2.9%
3/102 • Number of events 3 • 3 years
|
|
General disorders
Fatigue
|
81.4%
83/102 • Number of events 112 • 3 years
|
Additional Information
Clinicaltrials.gov/CTRP Specialist
Huntsman Cancer Institute/University of Utah
Phone: 8012136215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place