Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue
Condition: Cancer-related Fatigue
MeSH terms: Fatigue
Intervention: Thyrotropin releasing hormone (TRH); Placebo
Intervention description: 0.5mg and 1.5mg; Saline
Intervention MeSH terms: Hormones; Thyrotropin-Releasing Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer fatigue

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.
    

Eligibility criteria:

        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