Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy

NCT00152867 | Completed Phase 3

• 1 other identifier: MDJV2
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Dexamethasone is a steroid, which is often given into the vein before chemotherapy to help control acute nausea and vomiting. It can also be given as an oral tablet for patients to take for the two days following chemotherapy to help minimise delayed nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting, the use of dexamethasone is well proven. However, in chemotherapy regimens that generally cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone in the 48-hour period after chemotherapy is not well proven, although it is often prescribed. While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia, indigestion, anxiety and mood changes. While patients with less vomiting and nausea are expected to have better quality of life (QOL), for patients with minimal nausea or vomiting, their QOL might be more affected by the side effects of the dexamethasone treatment than by the nausea. Study Design: The study will be performed in patients who will be receiving first line chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute nausea/vomiting will be standardised and all patients will receive non-steroidal medication for delayed nausea control. Each patient will be randomly allocated to receive either oral dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for the first cycle of chemotherapy, and then crossed over to the other treatment for the second cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to determine the effect of dexamethasone on nausea and vomiting and the impact of both the side effects of dexamethasone, and of nausea and vomiting, on QOL. Objectives: The primary objectives are to determine patient preference for dexamethasone or placebo, and to compare changes in QOL after chemotherapy in patients who receive dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea; (2) to compare differences in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo. Significance: This study will provide data to evaluate whether the benefits of dexamethasone for delayed nausea and vomiting outweigh potential side effects in patients receiving chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea medication for delayed nausea after moderately nauseating chemotherapy should be limited to patients with poor initial control of nausea/vomiting.

Conditions

Cancer; Emesis; Nausea

Keywords

quality of life; dexamethasone; emesis

Outcome Measures

Primary Outcomes (2)

• Patient preference for the dexamethasone or the placebo arm as assessed by asking the patient whether they preferred treatment period 1 or treatment period 2

  dexamethasone for one cycle of chemotherapy and placebo for one cycle

• Difference in QOL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 for chemotherapy cycles 1 and 2

  dexamethasone for one cycle and placebo for one cycle

Secondary Outcomes (5)

• Differences in nausea and vomiting by treatment period and regimen

  post period 2

• Impact of nausea and vomiting on QOL by Functional Living Index-Emesis (FLIE) score by treatment period and regimen

  post period 2

• Symptoms and signs associated with dexamethasone use by treatment period and regimen: insomnia, indigestion/epigastric discomfort, hiccups, appetite, agitation, acne/facial rash, oral candida, depression, weight changes, blood pressure

  post period 2

• Strength of preference for treatment cycle including dexamethasone compared to treatment cycle including placebo (Much better, Little better, No difference)

  post period 2

• Proportion of patients having a clinically significant improvement in QOL (defined as an improvement in EORTC QLQ-C30 of 10 points or more) during each treatment cycle

  post period 2

Study Arms (2)

1

ACTIVE COMPARATOR

Dexamethasone

Drug: Dexamethasone

2

PLACEBO COMPARATOR

Placebo

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

dexamethasone 4mg PO bd for 2 days post chemotherapy

1; 2

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with breast cancer who will receive their first cycle of non-cisplatin moderately emetogenic chemotherapy. The following regimens can be administered:
• day regimens dose dense
• day regimens:
• Adriamycin and Cyclophosphamide (AC) + a Taxane (T) Other regimens are eligible as long as no cisplatin or other highly emetogenic agent is part of the regimen, and a moderately emetogenic agent is included.
• Aged \> 18 years
• Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale
• Full recovery from any post operative sequelae
• Patients on opioids are eligible as long as their doses are stable (no change to dose in the previous week) and they have no nausea or vomiting in the 24 hours prior to the study
• Informed signed consent

You may not qualify if:

• Patient has previously received chemotherapy
• Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to treatment
• Nausea or vomiting in the 24 hour period prior to commencing chemotherapy
• Use of antiemetics within 24 hours of the study period
• Patient has an active infection (e.g. pneumonia) or any uncontrolled disease (e.g. diabetes, gastrointestinal obstruction), which in the opinion of the investigator might confound the results of the study or pose unwarranted risk. Patients with controlled diabetes are eligible.
• Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
• Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.
• Patient has a history of hypersensitivity or contraindication to granisetron or dexamethasone.
• Patient is taking any systemic corticosteroid therapy at any dose. Topical or inhaled steroids are permitted.
• Use of benzodiazepines in the 48 hours prior to the study period with the exception of a single dose if used for sleeping.
• Abnormal laboratory values:
• Absolute neutrophil count \< 1.5 X 10\^9/L
• Platelet count \< 100 X 10\^9/L
• Liver transaminases \> 2.5 X upper limit of normal
• Bilirubin \> 1.5 X upper limit of normal

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Mount SinaiHospital

Toronto, Ontario, M5G 2M9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms; Vomiting; Nausea

Interventions

Dexamethasone

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

Study Officials

• Ian Tannock, MD PhD

  University Health Network University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: January 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

CA (2)