Contact information
Type
Scientific
Primary contact
Dr Florian Strasser
ORCID ID
Contact details
Head of Oncological Palliative Medicine
Oncology Section
Department of Internal Medicine and Palliative Care Centre
Department of Interdisciplinary Medical Services
Cantonal Hospital
Rorschacherstrasse 95
St.Gallen
9007
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SG 239 /03
Study information
Scientific title
Acronym
Study hypothesis
Patients with first taxane-based chemotherapy having a prophylaxis with oral glutamine have significantly less patient-perceived and objective taste alterations than those with placebo.
Ethics approval
Ethics Committee of the Canton St.Gallen, Switzerland. Approved on January 13th 2004 (ref: EKSG 03/080; Swissmedic 2004DR3015)
Study design
Single-center, randomized, double-blind, placebo-controlled, two-arm, parallel study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Taxane-associated dysgeusia
Intervention
The participants were randomly allocated to the following two arms:
Intervention arm: Glutamine (oral) 30 g per day in 2-3 doses
Control arm: Maltodextrin (as placebo) 30 g per day in 2-3 doses
The interventions for both groups started on the first day of the taxane-based chemotherapy.
Expected duration of intervention for 2 cycles of taxane-based chemotherapy 6-8 weeks, extension encouraged to 3 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Glutamine
Primary outcome measure
Taste alteration (dysgeusia), reported daily by the patient at the same time of the day (usually before dinner) answering the question Presently my sense of taste is ... using a Visual Analogue Scale (VAS: 0 mm = very good; 100 mm = very bad).
Secondary outcome measures
1. Taste recognition test, carried out at baseline, on day one of each chemotherapy cycle, and in addition on day 8 of the second chemotherapy cycle.
2. Adverse events
Overall trial start date
01/03/2004
Overall trial end date
31/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients with cancer receiving for the first time a taxane-containing chemotherapy
2. Written informed consent
3. Able to feed themselves
4. Eastern Cooperative Oncology Group (ECOG) PS 2 or less
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Previous surgery or radiotherapy of the oral or nasal region
2. Oral candidiasis
3. Zinc deficiency
4. Creatinine clearance of greater than or equal to 30 ml/min
Recruitment start date
01/03/2004
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Switzerland
Trial participating centre
Head of Oncological Palliative Medicine
St.Gallen
9007
Switzerland
Sponsor information
Organisation
Cantonal Hospital St.Gallen (Switzerland)
Sponsor details
Rorschacherstrasse 95
St. Gallen
9007
Switzerland
florian.strasser@kssg.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Swiss Group for Clinical Cancer Research (SIAK): Pilot development grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Eastern Switzerland Foundation of Clinical Cancer Research (OSKK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Baxter Switzerland (unrestricted grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list