Condition category
Signs and Symptoms
Date applied
01/10/2007
Date assigned
30/10/2007
Last edited
30/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes