Breast Cancer - Female
Conditions
Brief summary
This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. After informed consent is obtained from eligible subjects, they will then be electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3 weeks) and prior chemotherapy.
Detailed description
Subjects will be randomized to receive either melatonin or placebo. 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. Patients with localized breast cancer will receive standard-of-care RT as determined by the treating physician. The RT regimens include: (1) 1 week of accelerated (APBI); (2) 3-4 weeks of an accelerated hypofractionation RT schedule; and (3) 6-8 weeks of a standard RT schedule. No additional concomitant medication or supportive care guidelines are required for this study. Subjects will receive daily melatonin or placebo beginning the night before their course of RT and for an additional 2-week period that extends beyond the conclusion of their RT. Subjects will be given a Study Diary to record their use of study medication. Patients will be followed for 60 days after removal from the study treatment or until death, whichever occurs first. Patients removed from the study treatment for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the adverse event.
Interventions
DRUGMelatonin
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).
DRUGPlacebo
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).
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ambulatory outpatients with breast (including ductal carcinoma in situ \[DCIS\]) cancer. 2. Patients to be treated with RT for curative intent. 3. Women ≥18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Appendix 4). 5. Hemoglobin ≥ 9 g/dL 6. Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards. 7. Subjects who are currently taking melatonin must discontinue melatonin for 5 days before enrolling in the study. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected): * uncontrolled hypothyroidism (TSH \>10 IU) * hypercalcemia (calcium \>11 mg/dL) Calcium (Ca) = Serum Calcium (SerumCa) + 0.8 \* (NormalAlbumin - PatientAlbumin) * decompensated congestive heart failure * chronic obstructive pulmonary disease requiring oxygen replacement 2. Patients with a creatinine clearance \<30 mL/min 3. Aspartate aminotransferase (AST) \> 3X upper limit of normal (ULN) 4. Alanine aminotransferase (ALT) \> 3X ULN 5. Bilirubin \> 1X ULN 6. Use of systemic steroids, or other pharmacological agents such as methylphenidate for cancer-related fatigue 7. Current use of American ginseng, remelteon, or warfarin. 8. Depression ≥ grade 2 (CTCAE v4.0)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of FACIT-Fatigue Subscale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | 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). |
| 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. | 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. |
| Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue. | 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. |
| Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo. | 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 |
| Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 39 |
| 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). | 38 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cronavirus disease (COVID-19) Precautions | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | 20 mg Melatonin | Placebo |
|---|---|---|---|
| Age, Customized | 56.5 years | 54 years | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 39 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 27 Participants | 27 Participants |
| Region of Enrollment United States | 77 participants | 39 participants | 38 participants |
| Sex: Female, Male Female | 77 Participants | 39 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 1 / 38 |
| other Total, other adverse events | 37 / 39 | 37 / 38 |
| serious Total, serious adverse events | 0 / 39 | 3 / 38 |
Outcome results
Primary
Comparison of FACIT-Fatigue Subscale
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.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mg Melatonin | Comparison of FACIT-Fatigue Subscale | -4.39 score on a scale | Standard Error 1.24 |
| Placebo | Comparison of FACIT-Fatigue Subscale | 0.74 score on a scale | Standard Error 1.69 |
Secondary
Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo.
Determine whether patients receiving melatonin have fewer hospital admissions, emergency center visits, and medical days off work than patients receiving placebo
Time frame: Baseline (day 1) to 8 weeks post RT (variable, approximately 64 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| Placebo | Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo. | Emergency Department Visit | 3 Participants |
| Placebo | Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo. | Hospital Admission | 5 Participants |
| Placebo | 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 | 4 Participants |
Secondary
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.
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.
Time frame: Baseline (Day 1) and 8 weeks post RT (variable, approximately 64 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mg Melatonin | 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 |
| Placebo | 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. | 4.58 score on a scale | Standard Error 1.26 |
Secondary
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
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).
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Shortness of Breath | -0.44 score on a scale | Standard Error 0.18 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Anxiety | -0.69 score on a scale | Standard Error 0.32 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Nausea | 0.06 score on a scale | Standard Error 0.15 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Best Well Being | 0.41 score on a scale | Standard Error 0.49 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Tiredness | 0.28 score on a scale | Standard Error 0.51 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Depression | -0.34 score on a scale | Standard Error 0.31 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Pain Score | 1.48 score on a scale | Standard Error 0.52 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Drowsiness | 0.81 score on a scale | Standard Error 0.48 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Sleep | -0.07 score on a scale | Standard Error 0.62 |
| Placebo | Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT. | Change in Lack of Appetite | 0.47 score on a scale | Standard Error 0.29 |
Secondary
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.
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.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mg Melatonin | 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 |
| Placebo | 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. | 1.3 score on a scale | Standard Error 1.97 |
Secondary
Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT.
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.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mg Melatonin | 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 |
| Placebo | Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT. | -0.52 score on a scale | Standard Error 1.2 |
Secondary
Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue.
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.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 mg Melatonin | 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 |
| 20 mg Melatonin | 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 |
| Placebo | Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue. | FACIT | 0.74 score on a scale | Standard Error 1.69 |
| Placebo | Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue. | PROMIS | -0.52 score on a scale | Standard Error 1.2 |