Prophylactic oral glutamine for docetaxel or paclitaxel associated taste alterations in cancer patients: a randomised, placebo-controlled, double-blind study

ISRCTN ISRCTN18939629
DOI https://doi.org/10.1186/ISRCTN18939629
Secondary identifying numbers SG 239 /03
Submission date
01/10/2007
Registration date
30/10/2007
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Florian Strasser
Scientific

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

Study information

Study designSingle-center, randomized, double-blind, placebo-controlled, two-arm, parallel study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleProphylactic oral glutamine for docetaxel or paclitaxel associated taste alterations in cancer patients: a randomised, placebo-controlled, double-blind study
Study objectivesPatients 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(s)Ethics Committee of the Canton St.Gallen, Switzerland. Approved on January 13th 2004 (ref: EKSG 03/080; Swissmedic 2004DR3015)
Health condition(s) or problem(s) studiedTaxane-associated dysgeusia
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Glutamine
Primary outcome measureTaste 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 measures1. 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 study start date01/03/2004
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment52
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2004
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Head of Oncological Palliative Medicine
St.Gallen
9007
Switzerland

Sponsor information

Cantonal Hospital St.Gallen (Switzerland)
Hospital/treatment centre

Rorschacherstrasse 95
St. Gallen
9007
Switzerland

Email florian.strasser@kssg.ch

Funders

Funder type

Industry

Swiss Group for Clinical Cancer Research (SIAK): Pilot development grant

No information available

Eastern Switzerland Foundation of Clinical Cancer Research (OSKK)

No information available

Baxter Switzerland (unrestricted grant)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/03/2008 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.