The Effects of Thalidomide on Symptom Clusters

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00379353
First received: September 19, 2006
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer.


Condition Intervention Phase
Advanced Cancers
Drug: Thalidomide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Thalidomide on Symptom Clusters

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline [± 3 days], 2 weeks[± 3 days] and 4 weeks [± 3 days]


Secondary Outcome Measures:
  • Functional Assessment of Anorexia/Cachexia Therapy (FAACT) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    12-item symptom-specific subscale of the FACT-G designed to measure participants' additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern.

  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue.

  • Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session.

  • Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of >/= 5 indicates poor sleepers.

  • Change in Body Composition as Measured by Body Mass Index (BMI) [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: No ]
    BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person's weight and height.

  • Change in Serum Cytokines and Receptors [ Time Frame: Baseline to Day 15 ] [ Designated as safety issue: No ]
    Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression.


Enrollment: 32
Study Start Date: September 2006
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: Thalidomide
100 mg capsules orally, once a day for 14 days
Drug: Thalidomide
100 mg capsules orally, once a day for 14 days.
Placebo Comparator: Group 2: Placebo
Two placebo capsules orally, once a day for 14 days.
Drug: Placebo
Two placebo capsules orally, once a day for 14 days.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have weight loss of > 5% within the last 6 months
  2. Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom.
  3. Describe the symptoms as being present every day for a minimum of 2 weeks.
  4. Have no clinical evidence of cognitive failure
  5. Must be 18 years or older.
  6. Expect to live at least >/= 4 weeks
  7. Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months.
  8. Understand and sign written informed consent.
  9. Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea.
  10. Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety]
  11. Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration)
  12. May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment.

Exclusion Criteria:

  1. Have major contraindication to thalidomide, i.e. hypersensitivity.
  2. Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy.
  3. Are not able to complete the baseline assessment forms.
  4. Are pregnant or lactating.
  5. Patients with clinical history of seizures
  6. Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration).
  7. Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration).
  8. Patients on Revlimid (lenalidomide).
  9. Patients on investigational chemotherapy/agents.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379353

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00379353     History of Changes
Other Study ID Numbers: 2005-0980
Study First Received: September 19, 2006
Results First Received: July 3, 2012
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Anorexia
Fatigue
Thalidomide
Placebo

Additional relevant MeSH terms:
Syndrome
Neoplasms
Disease
Pathologic Processes
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014