Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.

NCT01913990 | Unknown Phase 4 DMC

• 1 other identifier: 2011348-01H
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emesis

Keywords

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms

  Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks

Other Outcomes (1)

• 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

  Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks

Study Arms (2)

Arm A: Standard Anti-emetic regimen

OTHER

The standard anti-emetic arm: In this arm the treating medical oncologist will determine the choice of anti-emetic regimen that they perceive the patient would require and prescribe it. The treating physician will be blinded to result of the personalized composite emesis score. The physician may or may not choose to prescribe an NK-1 inhibitor as the study will not predetermine the type of anti-emetics used. In the event that the patient experienced chemo induced nausea and vomiting (CINV), modifications to the initial anti emetic regimen would be left to the treating physician.

Other: Arm A: Standard Anti-emetic regimen

Arm B: Dexamethasone, Ondansetron, Aprepitant

EXPERIMENTAL

The emesis risk model arm: Prior to the start of intravenous chemotherapy an emesis risk score will be calculated for both acute and delayed emesis. The anti-emetic prophylaxis treatment will follow the emesis risk score. Whereby either an acute emesis score of ≥7 and/or a delayed emesis score of \>16 will be considered high-risk. The anti-emetics will be prescribed reflecting this risk for pre-chemotherapy, 8 hrs post chemotherapy and day 2-3 post chemotherapy. Dexamethasone, Ondansetron and Aprepitant will be given in different combination and doses depending on what score the participant receives based on their responses to the diary. For subsequent cycle the anti-emetic score will be re-calculated prior to each cycle and the choice of anti-emetics adjusted if necessary.

Drug: Dexamethasone, Ondansetron, Aprepitant

Interventions

Dexamethasone, Ondansetron, Aprepitant DRUG

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.

Also known as: Decadron, Zofran, Emend

Arm B: Dexamethasone, Ondansetron, Aprepitant

Arm A: Standard Anti-emetic regimen OTHER

Treating physician's discretion for type of anti-emetic to be prescribed.

Arm A: Standard Anti-emetic regimen

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Clemons M, Bouganim N, Smith S, Mazzarello S, Vandermeer L, Segal R, Dent S, Gertler S, Song X, Wheatley-Price P, Dranitsaris G. Risk Model-Guided Antiemetic Prophylaxis vs Physician's Choice in Patients Receiving Chemotherapy for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):225-31. doi: 10.1001/jamaoncol.2015.3730.

  PMID: 26562292 DERIVED

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Dexamethasone; Ondansetron; Aprepitant; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Morpholines; Oxazines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Mark Clemons, Dr.

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 1, 2013
• Study Start: September 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

CA (1)