Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT04526886
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy — OTHER
    Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy

Study Details

The study is testing an intervention of an investigator-developed chemotherapy dose adjustment algorithm. The primary objective of this study is to evaluate the effectiveness of the chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.

Key Dates

Start date
Oct 15, 2020
Status verified
Sep 2025
Primary completion
Mar 7, 2023
Completion
Mar 7, 2023

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.

Primary Outcome Measure

Unplanned Chemotherapy Treatment Delay [ Time Frame: Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-

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