Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study

NCT01797991 | Completed

• 1 other identifier: CE12.270
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study. The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel. Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.

Conditions

Prevention of Hypersensitivity Reactions to Paclitaxel

Keywords

Hypersensitivity, drug

Outcome Measures

Primary Outcomes (4)

• Quality of life assessed by the self-administered quality of life core questionnaire (QLQ-C30) version 3.0 from the European Organisation for Research and Treatment in Cancer (EORTC)

  Comparison of the scores according to the EORTC Scoring Manual.

  Day before chemotherapy (Day 0) of the first cycle of chemotherapy

• Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC

  Comparison of the scores according to the EORTC Scoring Manual.

  Day 6 of the first cycle of chemotherapy

• Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC

  Comparison of the scores according to the EORTC Scoring Manual.

  Day before chemotherapy (Day 0) of the second cycle of chemotherapy

• Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC

  Comparison of the scores according to the EORTC Scoring Manual.

  Day 6 of the second cycle of chemotherapy

Secondary Outcomes (6)

• Acute hypersensitivity reactions assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03

  During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy

• Acute hypersensitivity reactions assessed by the NCI CTCAE version 4.03

  During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy

• Use of rescue medication

  During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy

• Use of rescue medication

  During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy

• Adverse effects self-assessed by a personal logbook

  Assessed on a daily basis from Day 1 to Day 7 of the first cycle of chemotherapy

Study Arms (2)

Group A (dexamethasone per os)

ACTIVE COMPARATOR

* Dexamethasone 20 mg per os 12 hours and 6 hours before paclitaxel (form: opaque white capsules) * Matching placebo for dexamethasone IV (NaCl 0,9%) 30 minutes before paclitaxel

Drug: Dexamethasone per os; Drug: Matching placebo for dexamethasone IV

Group B (dexamethasone IV)

EXPERIMENTAL

* Dexamethasone 20 mg IV 30 minutes before paclitaxel * Matching placebo for dexamethasone per os (lactose capsule) 12 hours and 6 hours before paclitaxel (form: opaque white capsules)

Drug: Dexamethasone IV; Drug: Matching placebo for dexamethasone per os

Interventions

Dexamethasone per os DRUG

Group A (dexamethasone per os)

Matching placebo for dexamethasone IV DRUG

Group A (dexamethasone per os)

Dexamethasone IV DRUG

Group B (dexamethasone IV)

Matching placebo for dexamethasone per os DRUG

Group B (dexamethasone IV)

Eligibility Criteria

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

You may qualify if:

• Patient treated at the outpatient clinic or admitted to the oncology unit of Notre-Dame Hospital between February 4, 2013 and July 19, 2013;
• Patient diagnosed with cancer;
• Patient starting a chemotherapy containing paclitaxel every two to three weeks for a minimum of two cycles;
• Patient aged 18 years and over;
• Patient able to give free and informed consent and who agrees to participate by signing the consent form;
• Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the personal logbook.

You may not qualify if:

• Patient unable to speak English or French;
• Patient who has previously received paclitaxel;
• Patient receiving a prescription of paclitaxel bound to albumin;
• Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids during the last week;
• Patient in another research protocol evaluating a different chemotherapy regimen;
• Patient who had an allergic reaction to taxanes;
• Patient with severe intolerance to lactose;
• Patient with an allergy or a severe intolerance to products containing castor oil (eg.: cyclosporine and vitamin K).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Vanessa Samouelian, M.D., Ph. D.

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 25, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

CA (1)