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Anorexia Case Study Sections
 Author Bio
Introduction 
Commentator Bio
Protocol Schema
Protocol Background
Protocol Goals
Patient Eligibility
Test Schedule
Stratification Factors
Registration/Randomization
Protocol Treatment
Currently selected section: Dosage Modification
Ancillary Treatment
Toxicity Monitoring
Treatment Evaluation
Treatment/Follow-up
Ancillary Studies
Drug Information
Statistical Considerations
Pathology Considerations
Records/Data Collection Procedures
Budget
Appendices

 

Chapter 2A: Measuring Cancer Anorexia/Cachexia: A Case Study: Dosage Modification Based on Toxicity
 
 

8.0 Dosage Modification Based on Toxicity - If multiple toxicities are seen, administer dose based on greatest reduction required for any single toxicity observed. Reductions or increases apply to treatment given in the preceding cycle and are based on toxicities observed since the prior dose. The following are guidelines to be used with clinical judgment. Microphone Image

ALERT: ADR reporting may be required for some toxicities. See Section 10.

Toxicity
Agent
Dosage Change
Deep venous thrombosis or pulmonary embolus

Liquid
(Megace or placebo)

Discontinue liquid. Continue capsule.
Excessive weight gain
(>120% ideal body weight as a subjective guideline)
Liquid
(Megace or placebo)
Capsule
(Marinol or placebo)
Decrease both by 50% or stop at MD discretion.
Unacceptable weight loss after reducing or stopping dose
Liquid
(Megace or placebo)
Capsule
(Marinol or placebo)
Increase both back to original dose at MD discretion.
Unacceptable CNS toxicity
Capsule
(Marinol or placebo)
Decrease dose by 50% or discontinue capsule per physician discretion. Continue liquid.

Note: All dose modification rationale should be clearly documented on the flow sheet. When doses are modified for excessive weight gain, the patient should still be followed per protocol.


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