Trial Outcomes & Findings for 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 (NCT NCT00792077)

NCT ID: NCT00792077

Last Updated: 2021-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
• Results posted on: 2021-07-01

Participant Flow

Patients with Chronic lymphocytic leukemia were recruited from the Leukemia Clinic at the University of Texas MD Anderson Cancer Center.

Participant milestones

Measure	Lenalidomide Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
Overall Study STARTED	6
Overall Study Day 15+/- 3 Days	6
Overall Study Day 29+/-3 Days	6
Overall Study Day 43+/-3 Days	6
Overall Study Day 57+/-3 Days	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lenalidomide n=6 Participants Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Marital Status Divorced	2 Participants n=5 Participants
Marital Status Married	3 Participants n=5 Participants
Marital Status Separated	1 Participants n=5 Participants
Employment Status Full Time	2 Participants n=5 Participants
Employment Status Medical Leave	1 Participants n=5 Participants
Employment Status Part time	1 Participants n=5 Participants
Employment Status Unemployed	2 Participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Measure	Lenalidomide n=6 Participants Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
Total Sleep Time as Measured by Polysomnography (PSG)	-25.5 Minutes Interval -46.0 to -15.0

SECONDARY outcome

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

The FACIT-F subscale is a validated measure of fatigue. In the FACIT-F, the patient rates the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score can range between 0 and 52, with higher scores denoting less fatigue. The score 0= worst fatigue possible, 52 indicates no fatigue. The scores reported is the median (IQR) change at 8 weeks compared to baseline.

Outcome measures

Measure	Lenalidomide n=6 Participants Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score	4 score on a scale Interval -11.0 to 8.0

SECONDARY outcome

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

The Epworth sleep scale is an 8-item questionnaire designed to asses general level of daytime sleepiness, and scores on this instrument range form 0-24, with higher scores indicating greater sleepiness. It was measured as a change in total score between the before and after 1st cycle of treatment with Lenalidomide.

Outcome measures

Measure	Lenalidomide n=6 Participants Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
Epwort Sleep Scale	-1 score on a scale Interval -3.0 to 1.0

SECONDARY outcome

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

This criteria is used to assess how a patient's disease is progressing and to assess how the disease affects the daily living abilities of the patient. The scores on this instrument range from 0-5 (0=fully active and 5=dead), with higher scores indicating poorer performance. It was measured as a change in performance status between before and after 1st cycle of treatment with Lenalidomide.

Outcome measures

Measure	Lenalidomide n=6 Participants Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
ECOG Performance Status	0 score on a scale Interval 0.0 to 1.0

Adverse Events

Lenalidomide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sriram Yennu, MD- Professor, Palliative Care Med

UT MD Anderson Cancer Center

Phone: (713) 792-3938

Email: syennu@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place