Trial Outcomes & Findings for Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy (NCT NCT02332928)
NCT ID: NCT02332928
Last Updated: 2023-03-30
Results Overview
Determine if the average increase in fatigue (as measured by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Results posted on
2023-03-30
Participant Flow
Participant milestones
| Measure |
20 mg Melatonin
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
20 mg Melatonin
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Cronavirus disease (COVID-19) Precautions
|
1
|
0
|
Baseline Characteristics
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
Baseline characteristics by cohort
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
54 years
n=5 Participants
|
58 years
n=7 Participants
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)Determine if the average increase in fatigue (as measured by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Comparison of FACIT-Fatigue Subscale
|
-4.39 score on a scale
Standard Error 1.24
|
0.74 score on a scale
Standard Error 1.69
|
SECONDARY outcome
Timeframe: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)Determine whether the average increase in fatigue from baseline until 2 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Comparison of Functional Assessment of Chronic Illness Therapy (FACIT-F) Scores in Fatigue From Baseline Until 2 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo.
|
-2.78 score on a scale
Standard Error 1.5
|
1.3 score on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 8 weeks post RT (variable, approximately 64 weeks)Determine whether the average increase in fatigue from baseline until 8 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Comparison in Functional Assessment of Chronic Illness Therapy (FACIT) in Fatigue From Baseline Until 8 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo.
|
0.65 score on a scale
Standard Error 1.31
|
4.58 score on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)Average increase in symptoms from baseline until completion of RT for those patients who received melatonin compared to those who received placebo. The ESAS assesses 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity).
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Best Well Being
|
0.29 score on a scale
Standard Error 0.3
|
0.41 score on a scale
Standard Error 0.49
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Lack of Appetite
|
0.35 score on a scale
Standard Error 0.49
|
0.47 score on a scale
Standard Error 0.29
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Sleep
|
0.93 score on a scale
Standard Error 0.38
|
-0.07 score on a scale
Standard Error 0.62
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Tiredness
|
1.81 score on a scale
Standard Error 0.41
|
0.28 score on a scale
Standard Error 0.51
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Depression
|
-2 score on a scale
Standard Error 0.21
|
-0.34 score on a scale
Standard Error 0.31
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Drowsiness
|
1.39 score on a scale
Standard Error 0.39
|
0.81 score on a scale
Standard Error 0.48
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Nausea
|
0.19 score on a scale
Standard Error 0.14
|
0.06 score on a scale
Standard Error 0.15
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Anxiety
|
-0.26 score on a scale
Standard Error 0.48
|
-0.69 score on a scale
Standard Error 0.32
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Pain Score
|
0.74 score on a scale
Standard Error 0.45
|
1.48 score on a scale
Standard Error 0.52
|
|
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Change in Shortness of Breath
|
-0.29 score on a scale
Standard Error 0.26
|
-0.44 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)Determine whether the average increase in fatigue (as measured by the PROMIS Fatigue-Short Form 8a) from baseline to completion of RT is less in those patients who received melatonin compared to those who received placebo. The higher score, the worse fatigue. The PROMIS Fatigue-Short Form 8a scale consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT.
|
3.51 score on a scale
Standard Error 1.08
|
-0.52 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)Compare the scores obtained with the FACIT-Fatigue subscale and the PROMIS Fatigue-Short Form at completion of RT. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The PROMIS Fatigue-Short Form 8a scale. It consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
Outcome measures
| Measure |
20 mg Melatonin
n=40 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue.
FACIT
|
-4.39 score on a scale
Standard Error 1.24
|
0.74 score on a scale
Standard Error 1.69
|
|
Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue.
PROMIS
|
3.51 score on a scale
Standard Error 1.08
|
-0.52 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline (day 1) to 8 weeks post RT (variable, approximately 64 weeks)Determine whether patients receiving melatonin have fewer hospital admissions, emergency center visits, and medical days off work than patients receiving placebo
Outcome measures
| Measure |
20 mg Melatonin
n=39 Participants
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 Participants
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo.
Emergency Department Visit
|
6 Participants
|
3 Participants
|
|
Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo.
Hospital Admission
|
7 Participants
|
5 Participants
|
|
Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo.
Medical Day Off From Work
|
15 Participants
|
4 Participants
|
Adverse Events
20 mg Melatonin
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 37 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
20 mg Melatonin
n=39 participants at risk
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 participants at risk
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Investigations
Creatinine Increased
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Nervous System Disorders-Other, specify
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
Other adverse events
| Measure |
20 mg Melatonin
n=39 participants at risk
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Melatonin: Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
Placebo
n=38 participants at risk
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo: Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
94.9%
37/39 • Number of events 440 • 30 days following completion of treatment, an average of 20 weeks.
|
97.4%
37/38 • Number of events 346 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
2/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
30.8%
12/39 • Number of events 16 • 30 days following completion of treatment, an average of 20 weeks.
|
21.1%
8/38 • Number of events 10 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
4/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
3/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
7.9%
3/38 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.1%
2/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders- Other, specified
|
5.1%
2/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Nausea
|
25.6%
10/39 • Number of events 13 • 30 days following completion of treatment, an average of 20 weeks.
|
31.6%
12/38 • Number of events 15 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Edema Face
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Edema Limbs
|
5.1%
2/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Fatigue
|
82.1%
32/39 • Number of events 64 • 30 days following completion of treatment, an average of 20 weeks.
|
81.6%
31/38 • Number of events 53 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Flu Like Symptoms
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
General Disorders and Administration Site Conditions-Other Specified
|
12.8%
5/39 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Localized Edema
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.6%
1/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
General disorders
Pain
|
25.6%
10/39 • Number of events 15 • 30 days following completion of treatment, an average of 20 weeks.
|
21.1%
8/38 • Number of events 12 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Infections and infestations
Breast Infection
|
2.6%
1/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
64.1%
25/39 • Number of events 41 • 30 days following completion of treatment, an average of 20 weeks.
|
71.1%
27/38 • Number of events 40 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Infections and infestations
Creatinine Increased
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
5.1%
2/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective Tissue Disorder - Other, Specify
|
7.7%
3/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/39 • Number of events 39 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.3%
4/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Dizziness
|
41.0%
16/39 • Number of events 22 • 30 days following completion of treatment, an average of 20 weeks.
|
23.7%
9/38 • Number of events 14 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Dysgeusia
|
5.1%
2/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Headache
|
53.8%
21/39 • Number of events 35 • 30 days following completion of treatment, an average of 20 weeks.
|
39.5%
15/38 • Number of events 26 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Nervous System Disorder-Other, Specify
|
5.1%
2/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
5.3%
2/38 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
10.3%
4/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Nervous system disorders
Somnolence
|
69.2%
27/39 • Number of events 45 • 30 days following completion of treatment, an average of 20 weeks.
|
55.3%
21/38 • Number of events 34 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Anxiety
|
46.2%
18/39 • Number of events 29 • 30 days following completion of treatment, an average of 20 weeks.
|
39.5%
15/38 • Number of events 19 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Confusion
|
17.9%
7/39 • Number of events 12 • 30 days following completion of treatment, an average of 20 weeks.
|
13.2%
5/38 • Number of events 6 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Depression
|
41.0%
16/39 • Number of events 24 • 30 days following completion of treatment, an average of 20 weeks.
|
47.4%
18/38 • Number of events 29 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Insomnia
|
15.4%
6/39 • Number of events 9 • 30 days following completion of treatment, an average of 20 weeks.
|
10.5%
4/38 • Number of events 7 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Irritability
|
23.1%
9/39 • Number of events 9 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Psychiatric disorders
Restlessness
|
5.1%
2/39 • Number of events 2 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Reproductive system and breast disorders
Breast Pain
|
17.9%
7/39 • Number of events 9 • 30 days following completion of treatment, an average of 20 weeks.
|
18.4%
7/38 • Number of events 8 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
3/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/39 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
2/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
2.6%
1/38 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.3%
4/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
7.9%
3/38 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
12.8%
5/39 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
18.4%
7/38 • Number of events 8 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
5.1%
2/39 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
0.00%
0/38 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Vascular disorders
Hot Flashes
|
10.3%
4/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
10.5%
4/38 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Number of events 4 • 30 days following completion of treatment, an average of 20 weeks.
|
7.9%
3/38 • Number of events 3 • 30 days following completion of treatment, an average of 20 weeks.
|
|
Vascular disorders
Lymphedema
|
2.6%
1/39 • Number of events 1 • 30 days following completion of treatment, an average of 20 weeks.
|
7.9%
3/38 • Number of events 5 • 30 days following completion of treatment, an average of 20 weeks.
|
Additional Information
Massey Cancer Center Cancer Prevention & Control Team
Virginia Commonwealth University Massey Cancer Center
Phone: 877-462-7739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place