Skip to main content
OpenTrials
Completed

NCT Number: NCT02635984

Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complications of Bone Marrow Transplant Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

About this study

Nausea and vomiting remains a common and difficult to manage consequence of chemotherapy despite prophylaxis. These symptoms can often lead to a decreased quality of life, dehydration, and malnutrition. Olanzapine is an atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. Olanzapine has been studied for breakthrough chemo-induced nausea and vomiting (CINV) as well as in prophylaxis of highly and moderately emetogenic regimens (HEC and MEC, respectively). However, these studies have focused on patients with solid tumor malignancies and chemotherapy regimens of short duration. To date, no publications have reported outcomes from adding olanzapine to standard triplet therapy, for hematology patients, including those undergoing hematopoietic stem cell transplants and those who receive multi-day HEC and MEC regimens.

This is a blinded, placebo controlled trial randomizing patients to receive olanzapine 10 mg orally on all chemotherapy days plus three additional days post chemotherapy or placebo in addition to standard triplet therapy (ondansetron and dexamethasone on each day of chemotherapy and fosaprepitant 150 mg IV on day one of chemotherapy). Inclusion criteria: age 18 or older, receiving inpatient or outpatient HEC or MEC chemotherapy including those regimens given before stem cell transplantation (ABVD, ICE ± R, 7+3 or 5+2, BEAM, Bu/Cy ± ATG, Bu/Flu ± ATG, FluCy ± ATG, BuMel, FluBuCy, Melphalan). Exclusion criteria: allergy to olanzapine, documented nausea/vomiting ≤24 hours before enrollment, treatment with other antipsychotic agents, or declined informed consent. Patients will be randomized to placebo or olanzapine in a block design stratified by chemotherapy type (transplant conditioning vs. chemotherapy only) and number of days of chemotherapy (single vs. multi-day) by the Investigational Drug Pharmacy services at Augusta University Medical Center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient or outpatient hematology patient receiving one of the following regimens:
  • Chemotherapy for hematologic malignancy:
  • ABVD
  • ICE ± R
  • 7+3
  • Conditioning therapy for stem cell transplantation:
  • BEAM
  • Bu/Cy ± ATG
  • Bu/Flu ± ATG
  • FluCy ± ATG
  • FluCy + TBI
  • BuMel
  • FluBuCy
  • Melphalan
  • Etoposide + TBI
  • Cyclophosphamide + TBI

Exclusion criteria

  • Allergy to olanzapine
  • Documented nausea or vomiting ≤24 hours prior to enrollment
  • Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy
  • Chronic alcoholism
  • Pregnant
  • Declined or unable to provide an informed consent

Treatment and study plan

Olanzapine

Drug

Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Other names: Zyprexa

Placebo

Drug

Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

Primary outcomes

  1. Overall Percentage of Patients Who Had a Complete Response

    Time frame: Until study completion; estimated 1.5 years

    Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.

Secondary outcomes

  1. Percent of Patients With no Significant Nausea in Overall Assessment Period

    Time frame: Until study completion; estimated 1.5 years

    Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm

  2. Percent of Patients Achieving Complete Protection in Overall Assessment Phase

    Time frame: Until study completion; estimated 1.5 years

    (CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]

  3. Percent of Participants With no Significant Nausea in Acute Phase

    Time frame: Until study completion; estimated 1.5 years

    Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy

  4. Percent of Participants With no Significant Nausea in Delayed Phase

    Time frame: Until study completion; estimated 1.5 years

    Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm

  5. Percent of Patients With no Nausea in Overall Assessment Period

    Time frame: Until study completion; estimated 1.5 years

    No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)

  6. Percent of Patients With Complete Response in Acute Phase

    Time frame: Until study completion; estimated 1.5 years

    Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)

  7. Percent of Patients With Complete Response in Delayed Phase

    Time frame: Until study completion; estimated 1.5 years

    Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • University of Georgia

Registry information

Official study title

Randomized, Placebo Controlled Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Versus FOND+O (FOND Plus Olanzapine) for the Prevention of Chemotherapy Induced Nausea and Vomiting in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

Acronym: FOND-O

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2015
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.