This randomized phase II trial studies how well minocycline hydrochloride works in reducing symptom burden in patients with colorectal cancer. Minocycline hydrochloride may reduce neuropathy (nerve damage that can include numbness, pain, and/or loss of motor function) caused by chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01906008.
PRIMARY OBJECTIVES:
I. To examine the clinical efficacy of minocycline (minocycline hydrochloride) in reducing acute peripheral neuropathy during oxaliplatin-based chemotherapy in patients with colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To examine the clinical efficacy of minocycline in reducing fatigue during oxaliplatin-based chemotherapy in patients with CRC.
II. To examine the impact of socioeconomic status (SES) on the clinical efficacy of minocycline in reducing acute peripheral neuropathy during oxaliplatin-based chemotherapy in patients with CRC.
III. To examine the interaction between SES and inflammation (circulating cytokines and activation of immune cells) and the effect of these variables on symptom severity in CRC patients.
IV. To explore the relationship between objective measures of neuropathy and patient-reported symptom outcome measures and health status.
OUTLINE: Patients randomized to 1 of 2 treatment arms.
GROUP I: Patients receive placebo orally (PO) twice daily (BID) beginning at chemotherapy initiation and continuing for 4 months.
GROUP II: Patients receive minocycline hydrochloride PO BID beginning at chemotherapy initiation and continuing for 4 months.
After completion of study treatment, patients are followed up at 2 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorCathy Eng