This phase II trial studies loratadine in treating bone pain in patients with aggressive lymphoma receiving pegfilgrastim. Initial treatment of aggressive lymphoma may result in a lower-than-normal number of blood cells. Colony-stimulating factors, such as pegfilgrastim, increase the production of blood cells. Loratadine may help relieve bone pain caused by pegfilgrastim and may help improve quality of life in patients with aggressive lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT02392039.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Evaluate the effect of loratadine and placebo on bone pain related quality of life (QOL) measured by Functional Assessment of Cancer Therapy-Bone Pain (FACT-BP) after pegfilgrastim given to lessen chemotherapy-induced neutropenic complications in patients with lymphomas.
SECONDARY OBJECTIVES:
I. Evaluate the effect of loratadine and placebo on need for pain medication after pegfilgrastim.
II. Evaluate the effect of loratadine and placebo on recovery of neutrophil count after pegfilgrastim.
TERTIARY OBJECTIVES:
I. Evaluate the effect on quality of life of loratadine and placebo with pegfilgrastim.
II. Evaluate the effect of loratadine and placebo on lactate dehydrogenase and alkaline phosphatase after pegfilgrastim.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Beginning 24-72 hours after completion of chemotherapy, patients receive pegfilgrastim subcutaneously (SC) on day 1, loratadine orally (PO) on days 1-7 of courses 1 and 3, and placebo PO on days 1-7 of courses 2 and 4. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
GROUP II: Beginning 24-72 hours after completion of chemotherapy, patients receive pegfilgrastim SC on day 1, placebo PO on days 1-7 of courses 1 and 3, and loratadine PO on days 1-7 of courses 2 and 4. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with bone pain during courses 1-4 may continue to receive pegfilgrastim SC on day 1 and loratadine PO on days 1-7. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJason Westin
