Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01913990
Other study ID # 2011348-01H
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received July 22, 2013
Last updated January 27, 2017
Start date September 2011
Est. completion date December 2017

Study information

Verified date January 2017
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 323
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility Inclusion Criteria:

Newly diagnosed invasive breast cancer (stage I-III)

Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy;

Able to consent and fill study forms

Exclusion Criteria:

Received previous chemotherapy

Symptoms of nausea or vomiting at baseline (disease related)

On chronic anti-emetic therapy

On daily corticosteroids prior to initiation of chemotherapy

Allergic to steroids, 5HT3 or NK-1

Uncontrolled diabetes

Medical or psychiatric illness that would interfere with patients' ability to complete the diary

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone, Ondansetron, Aprepitant
Arm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary.
Other:
Arm A: Standard Anti-emetic regimen
Treating physician's discretion for type of anti-emetic to be prescribed.

Locations

Country Name City State
Canada The Ottawa Hospital Cancer Centre Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Difference in breakthrough anti-emetic use in the emesis risk model group compared to the standard arm; i.e.: requirements for additional oral and parenteral anti-emetics during a single chemotherapy cycle The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains—one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Primary Incidence of change in acute emesis (nausea and/or vomiting) in both study arms The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains—one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Secondary Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains—one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
See also
  Status Clinical Trial Phase
Terminated NCT00869973 - Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients Phase 3
Terminated NCT00869310 - Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis Phase 3
Completed NCT04719286 - MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy N/A
Completed NCT01046240 - Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy Phase 1/Phase 2
Recruiting NCT03478605 - Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis Phase 2
Recruiting NCT04564144 - Evaluation of Meclizine Orodispersible Tablet Pharmacokinetic in Human Volunteers Phase 1/Phase 2
Terminated NCT01148264 - Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis Phase 2
Completed NCT01509417 - Different Feeding Methods After Pyloromyotomy N/A
Completed NCT00152867 - Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy Phase 3
Completed NCT04182750 - Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study N/A
Completed NCT02980289 - DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
Completed NCT02602080 - Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Completed NCT04585841 - The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy Phase 1
Completed NCT01414478 - High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor N/A
Not yet recruiting NCT02407600 - Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy Phase 2