A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue

NCT00792077 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2007-0945NCI-2012-01661
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if treatments to kill cancer cells including lenalidomide and/or radiation therapy can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast cancer.

Conditions

Leukemia; CLL

Keywords

Leukemia; Lenalidomide; Actigraph; Sleep Test Study; Chronic Lymphocytic Leukemia; CC-5013; Revlimid

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time as Measured by Polysomnography (PSG)

  Polysomnography (PSG) was done to measure the total sleep time in minutes. It was measured as a change in total sleep time between the before and after 1st cycle of treatment with Lenalidomide.

  before and after 1st cycle of Lenalidomide treatment, up to 8 weeks

Secondary Outcomes (3)

• The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score

  before and after 1st cycle of Lenalidomide treatment, up to 8 weeks

• Epwort Sleep Scale

  before and after 1st cycle of Lenalidomide treatment, up to 8 weeks

• ECOG Performance Status

  before and after first cycle of Lenalidomide treatment, up to 8 weeks

Study Arms (1)

Sleep time

EXPERIMENTAL

Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF): Lenalidomide + Actigraph + Questionnaire + Sleep Test

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

5 mg daily for 56 days.

Also known as: CC-5013, Revlimid

Sleep time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
• Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
• Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
• Have a MDAS of 13 or less.
• Able to understand the description of the study and give written informed consent.

You may not qualify if:

• Patients who are unable to complete the assessment measures or refuse to participate
• Patients with known history of brain metastasis.
• Patients with known history of sleep apnea.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sriram Yennu, MD- Professor, Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennurajalingam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 2008
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Locations

US (1)