Cancer-related Fatigue
Conditions
Keywords
cancer fatigue
Brief summary
The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a treatment for cancer-related fatigue. The central hypothesis of this pilot study is that TRH is more efficacious than placebo in alleviating cancer-related fatigue in patients with breast or prostate cancer.
Interventions
0.5mg and 1.5mg
DRUGPlacebo
Saline
Sponsors
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of cancer who have undergone or are currently undergoing radiation or chemotherapy therapy and are expected not to have any significant change in cancer treatment sessions during the study period * Provide written informed consent prior to initiation of any study-related procedures. * Male or female, 18 years of age or older with a diagnosis of cancer. * Able to understand and comply with the requirements of the study.
Exclusion criteria
* Hospitalized patients. * Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria. * Patients with any of the following cardiovascular symptomatology. * Office systolic BP \> 160mmHg and/or diastolic BP \> 90mmHg. * Persons with a resting hear rate of \> 100 beats per minute * Persons with a history of chronic stable angina * Persons with myocardial infarction or unstable angina or vascular surgery within 6 months * Persons with history of vaso-vagal or other syncopal episodes * Patients with any known clinically significant cardiac problems * Patients with any history of stroke or at significant risk for stroke. * Patients with a history of seizures * Patients with a history of asthma * Patients with any clinically significant unstable or inadequately treated co- morbid medical condition or patients currently on medications that would confound evaluation of CF (e.g. diabetes, CHF, history of other cancers) as judged by the investigator. * Patients with any clinically significant, unstable psychiatric disorder (except mild to moderate depressive or anxiety disorders) or patients on psychotropic medications that would confound CF assessment as judged by the investigator. Patients with history of depressive or anxiety disorders will not be excluded from the study * Patients with a history of illnesses or treatments that would be expected to significantly alter immune function (viz. HIV infection, systemic lupus erythematosus, patients taking immunosuppressive medications). * Patients with diseases or on medications that significantly affect the hypothalamic-pituitary-adrenocortical (HPA) axis function (viz. Cushings disease). * Pregnant patients, breastfeeding or plans to become pregnant during the study * Patients with known allergy to TRH * Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment, confound CF evaluation or could interfere with the patient's participation in the study. * Patients with medically reversible causes of CF (viz., anemia, hypothyroidism, electrolyte abnormalities etc). * Patients with potentially treatable associated symptoms dominating the CF scenario such as pain, or sleep disturbances which may have a significant causal relationship to CF. * Patients identified as pregnant based on the pregnancy test during screening. * Patients physically unable to complete the walking test (WT) assessment or when the WT would increase risk for medical complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion | Baseline and 7 hours post study medication infusion | 1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited per referrals from oncology clinics at UCHC and Gray Cancer Center at Hartford Hospital
Pre-assignment details
Two participants signed informed consent but was not randomized as she did not meet study eligibility criteria
Participants by arm
| Arm | Count |
|---|---|
| TRH Then Saline TRH (0.5mg) given first followed by Saline | 5 |
| Saline Then TRH Saline given first followed by TRH (0.5 mg) | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Did not meet study eligibility criteria | 1 | 1 |
Baseline characteristics
| Characteristic | TRH Then Saline | Saline Then TRH | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9.4 | 58 years STANDARD_DEVIATION 9.4 | 58 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.
Time frame: Baseline and 7 hours post study medication infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thyrotropin-releasing Hormone (TRH) | Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion | 14.67 Scores on a scale | Standard Deviation 21.1 |
| Saline | Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion | -1.67 Scores on a scale | Standard Deviation 16 |