Trial Outcomes & Findings for Levocarnitine in Treating Fatigue in Cancer Patients (NCT NCT00091169)

Last Updated: 2023-07-05

Results Overview

Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

376 participants

Primary outcome timeframe

assessed at baseline and 4 weeks after randomization

Results posted on

2023-07-05

Participant Flow

This study was activated on 11/3/2005, accrued its first patient 12/16/2005, suspended on 5/4/2006 after reaching its original accrual goal (160 eligible patients), reactivated on 9/6/2006 after the accrual target amendment (286 eligible patients) was approved, and closed on 1/23/2007 with a total accrual of 376 patients.

Participant milestones

Participant milestones
Measure	Levocarnitine Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Overall Study STARTED	189	187
Overall Study Treated	163	170
Overall Study COMPLETED	132	134
Overall Study NOT COMPLETED	57	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Levocarnitine Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Overall Study Disease progression	3	1
Overall Study Adverse Event	11	17
Overall Study Death	4	1
Overall Study Withdrawal by Subject	10	13
Overall Study Other	3	4
Overall Study Not start protocol therapy	26	17

Baseline Characteristics

Levocarnitine in Treating Fatigue in Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levocarnitine n=189 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=187 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally	Total n=376 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	62 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	79 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	108 Participants n=7 Participants	186 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at baseline and 4 weeks after randomization

Population: All randomized patients

Outcome measures

Outcome measures
Measure	Levocarnitine n=189 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=187 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks	-0.96 units on a scale Interval -1.32 to -0.6	-1.11 units on a scale Interval -1.44 to -0.78

SECONDARY outcome

Timeframe: assessed at baseline and 4 weeks after randomization

Population: All randomized patients who reported FACIT-F score at both baseline and 4 weeks

Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.

Outcome measures

Outcome measures
Measure	Levocarnitine n=145 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=139 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks	5.36 units on a scale Interval 3.71 to 7.01	4.04 units on a scale Interval 2.39 to 5.69

SECONDARY outcome

Timeframe: assessed at baseline and 4 weeks after randomization

Population: All randomized patients who reported CES-D score at both baseline and 4 weeks

Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.

Outcome measures

Outcome measures
Measure	Levocarnitine n=145 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=139 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline	-3.05 units on a scale Interval -4.45 to -1.65	-2.91 units on a scale Interval -4.21 to -1.61

SECONDARY outcome

Timeframe: assessed at baseline and 4 weeks after randomization

Population: All randomized patients who reported BPI score at both baseline and 4 weeks

Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.

Outcome measures

Outcome measures
Measure	Levocarnitine n=133 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=138 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks	-0.19 units on a scale Interval -0.525 to 0.145	-0.08 units on a scale Interval -0.434 to 0.274

SECONDARY outcome

Timeframe: assessed at 4 weeks after randomization

Population: All randomized patients who had carnitine data at 4 weeks

Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine \> 0.4 μmol/L or free carnitine \< 35 μmol/L for males and \< 25 μmol/L for females.

Outcome measures

Outcome measures
Measure	Levocarnitine n=133 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=132 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Prevalence of Carnitine Deficiency at 4 Weeks	0.113 proportion of participants Interval 0.064 to 0.179	0.333 proportion of participants Interval 0.254 to 0.421

SECONDARY outcome

Timeframe: assessed at baseline and 4 weeks after randomization

Population: All randomized patients who had performance status data at baseline and 4 weeks

Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.

Outcome measures

Outcome measures
Measure	Levocarnitine n=155 Participants Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=160 Participants Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Proportion of Patients With Stable or Improving Performance Status at 4 Weeks	0.806 proportion of participants Interval 0.735 to 0.865	0.875 proportion of participants Interval 0.814 to 0.922

Adverse Events

Levocarnitine

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Levocarnitine n=166 participants at risk Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=171 participants at risk Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Blood and lymphatic system disorders Anemia	6.0% 10/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	5.3% 9/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment

Additional Information

Study statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Levocarnitine n=166 participants at risk Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally	Placebo n=171 participants at risk Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
Blood and lymphatic system disorders Anemia	0.00% 0/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Platelets decreased	0.00% 0/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Cardiac disorders Atrial fibrillation	0.00% 0/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
General disorders Fatigue	1.2% 2/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Pruritus/itching	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Rash/desquamation	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - disease progression NOS	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	1.2% 2/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Anorexia	0.00% 0/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Constipation	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea w/o prior colostomy	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	1.8% 3/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Nausea	1.2% 2/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	1.2% 2/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Vomiting	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Infections and infestations Infection w/ unk ANC urinary tract NOS	0.60% 1/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Abdomen, pain	0.00% 0/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.58% 1/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	1.2% 2/166 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment	0.00% 0/171 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment