Symptoms and General Pathology

All Conditions

Fatigue

All Drugs and Chemicals

Hormones

Thyrotropin-Releasing Hormone

Hormone Antagonists

Thyrotropin releasing hormone (TRH)

Placebo

Andrew Winokur, MD PhD

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.

Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue

A Pilot, Randomized Double-Blind Placebo-Controlled Crossover Study of Synthetic Thyrotropin Releasing Hormone (TRH) Administration for the Treatment of Fatigue in Patients With Cancer

1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.

Susan G. Komen Breast Cancer Foundation

Hollfelder foundation

UConn Health

TRH given as 0.5mg and 1.5mg intravenously

Thyrotropin-releasing Hormone (TRH)

Saline

TRH (0.5mg) given first followed by Saline

TRH Then Saline

Saline given first followed by TRH (0.5 mg)

Saline Then TRH

Total

Age, Continuous

Sex: Female, Male

Andrew Winokur MD PhD

Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion

Overall Study

Recurrence

Body Weight

Weight Loss

Body Weight Changes

Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

Anamorelin Hydrochloride

Exercise Intervention

Laboratory Biomarker Analysis

Nutritional Assessment

Quality-of-Life Assessment

Questionnaire Administration

Sriram Yennu

This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

PRIMARY OBJECTIVES:

I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.

SECONDARY OBJECTIVES:

I. To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.

II. To examine the side effects and tolerability of anamorelin in these patients.

EXPLORATORY OBJECTIVES:

I. To explore the effects of anamorelin and standardized physical activity and nutritional counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk test, day time activity \[accelerometer\], body composition \[as measured by INBODY\], and resting energy expenditure \[measured by indirect calorimetry\]).

II. To characterize the effects of anamorelin on potential inflammatory biomarkers of cancer-related fatigue (CRF) (C-Reactive Protein \[CRP\], monocyte IL-6\&R, TNF-a\&R, IL-10, IL-8, IL-1\&RA; IGF-1).

III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).

IV. To determine the association between change in FACIT-F scores and changes in muscle function, day time activity, and body composition, in patients with advanced cancer receiving oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.

OUTLINE:

Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

After completion of study treatment, patients are followed up on day 71.

Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors

Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer

FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.

The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.

The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.

The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.

Anamorelin

Race (NIH/OMB)

United States

Region of Enrollment

Lung

Gastrointestinal

Breast

Gynecological

Head and Neck

Cancer Type

Full time

Retired

Homemaker

Unemployed

Not Reported

Employment Status

Divorced

Married

Single / never married

Widowed

Marital Status

Dr. Sriram Yennu, Professor, Palliative Care Med

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

The Edmonton Symptom Assessment Scale (ESAS)-Fatigue

Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue

Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Neoplasm Metastasis

Syndrome

Lymphoma

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Cognitive Behavior Therapy

This trial studies how well cognitive behavioral therapy works in helping patients with acute myeloid leukemia or lymphoma with cancer-related fatigue. Behavioral therapy uses methods to help patients change the way they think and act. Behavioral skills may help patients with acute myeloid leukemia or lymphoma cope with anxiety, depression, and other factors that may influence their level of cancer-related fatigue.

PRIMARY OBJECTIVES:

I. To determine whether acute myeloid leukemia (AML) and lymphoma patients with cancer-related fatigue (CRF) will be satisfied with the cognitive behavioral therapy (CBT) intervention, and if CBT will be feasible for AML and lymphoma patients with CRF where the feasibility will be based on adherence measurement.

SECONDARY OBJECTIVES:

I. To examine the preliminary effects of CBT on improvement of CRF (Functional Assessment of Cancer Illness Therapy (FACIT-F) - Fatigue subscale, its related symptoms, M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety Depression Scale (HADS), and Quality of Life (FACT-G) in AML and lymphoma patients receiving this combination regimen at the end of 8 weeks or 6 months.

EXPLORATORY OBJECTIVES:

I. To explore the effects of CBT on hope for future and burdens of treatment and their interference with patients' lives using the Herth Hope Index (HHI), and MDASI-AML/MDS.

OUTLINE:

Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue

Cognitive Behavioral Therapy (CBT) Intervention for Cancer Related Fatigue (CRF) in Patients With AML and Lymphoma

To determine if patients are satisfied with CBT, based on equal to or more than 75% of patients indicating their satisfaction with CBT with a rating of "somewhat satisfied" or "completely satisfied". Satisfaction will be assessed using a 5 point, fully word-anchored balanced bipolar scale (Satisfaction Assessment).

MDASI symptom questionnaire answers range from 0 meaning "Not Present" to 10 meaning "As Bad as You Can Imagine".

Infections

Wounds and Injuries

Communicable Diseases

Leukemia, Lymphoid

Anemia

Thrombocytopenia

Hyperthermia

Lymphadenopathy

Leukemia, Lymphocytic, Chronic, B-Cell

Fever

Leukemia, Prolymphocytic

Lymphocytosis

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Blood Platelet Disorders

Cytopenia

Leukocytosis

Leukocyte Disorders

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Richter Syndrome

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.

Ex Vivo-activated Autologous Lymph Node Lymphocytes

Chitra Hosing

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)

Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.

To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia

The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.

To study the incidence of infections for up to 1 year following activated T cell infusion

Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.

Receive lymphodepletion chemotherapy followed by activated T-cell infusion

Arm A

Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L

Arm B

Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion

Arm C

Age, Categorical

Ethnicity (NIH/OMB)

All patients were enrolled in Arm C at the physician's discretion and there is no analysis to compare between the lenalidomide Arm A vs the non-lenalidomide Arm B

Dr. Chitra Hosing / Stem Cell Transplantation

Sucessful Target T-cell Dose

Feasibility

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.

Data was not collected due to low accrual

Immune Reconstitution

Overall Response Rates

Incidence of Infections

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue	NCT00790296	Cancer-related ...	Thyrotropin rel... Placebo	18 Years -	UConn Health
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors	NCT03035409	Advanced Malign... C-Reactive Prot... Cancer Fatigue Metastatic Mali... Recurrent Malig... Weight Loss	Anamorelin Hydr... Exercise Interv... Laboratory Biom... Nutritional Ass... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue	NCT03747757	Acute Myeloid L... Acute Myeloid L... Cancer Fatigue Lymphoma Secondary Acute...	Cognitive Behav... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia	NCT02530515	Anemia Cancer Fatigue Chronic Lymphoc... Fever Infectious Diso... Lymphadenopathy Lymphocytosis Night Sweats Prolymphocytic ... Recurrent Chron... Richter Syndrom... Secondary Malig... Thrombocytopeni... Weight Loss	Ex Vivo-activat... Laboratory Biom...	-	M.D. Anderson Cancer Center
Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue	NCT00790296	Cancer-related ...	Thyrotropin rel... Placebo	18 Years -	UConn Health

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