• Prevalence of carnitine deficiency [ Designated as safety issue: No ]
• Changes in levels of fatigue [ Designated as safety issue: No ]
• Effect on pain and performance status at 4 and 8 weeks [ Designated as safety issue: No ]
• Score changes in the BFI and the Brief Pain Inventory [ Designated as safety issue: No ]
• Survival [ Designated as safety issue: Yes ]
• Toxicity [ Designated as safety issue: No ]

• Prevalence of carnitine deficiency
• Changes in levels of fatigue
• Effect on pain and performance status at 4 and 8 weeks
• Score changes in the BFI and the Brief Pain Inventory
• Survival
• Toxicity

RATIONALE: Levocarnitine may help improve energy levels in cancer patients.

PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients.

OBJECTIVES:

Primary

• Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.

Secondary

• Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.
• Assess changes in the levels of fatigue at its worst.
• Assess the effect of levocarnitine on pain and performance status at 4 and 8 weeks of follow-up.
• Assess score changes in the items of the Brief Fatigue Inventory and the Brief Pain Inventory.
• Explore the association between carnitine (and acetyl levocarnitine) deficiency and fatigue and other selected covariates.
• Present the toxicity profiles of all patients.
• Measure serum levels of the pro-inflammatory cytokines IL-1, IL-6, TNF-α, the growth factors TGF-α, EGF, NRG-1, VEGF, and triglycerides (TG) and correlate with fatigue and other oncobehavioral symptoms.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, ECOG performance status (0-1 vs 2-3), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
• Arm II: Patients receive oral placebo twice daily on weeks 1-4. After week 4, all patients receive oral L-carnitine twice daily on weeks 5-8.

Fatigue is assessed at baseline and then at weeks 4 and 8.

PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

• Dietary Supplement: levocarnitine
• Other: placebo

• Experimental: Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
• Placebo Comparator: Patients receive oral placebo twice daily on weeks 1-4.

DISEASE CHARACTERISTICS:

• Diagnosis of an invasive malignant disorder
• Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a scale of 0-4) on the FACIT-F question "I feel fatigued"
• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 9 g/dL

Hepatic

• No severe, uncontrolled liver disease

Renal

• No evidence of severely compromised renal function including any 1 of the following:

  • Renal failure
  • End stage renal disease
  • Ongoing renal dialysis

Cardiovascular

• No severe, uncontrolled cardiovascular disease

Pulmonary

• No severe, uncontrolled pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No history of seizures
• No known sensitivity to carnitine
• No delirium
• No nausea > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine