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
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 design | Single-center, randomized, double-blind, placebo-controlled, two-arm, parallel study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Prophylactic oral glutamine for docetaxel or paclitaxel associated taste alterations in cancer patients: a randomised, placebo-controlled, double-blind study |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2004 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 52 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Head of Oncological Palliative Medicine
St.Gallen
9007
Switzerland
9007
Switzerland
Sponsor information
Cantonal Hospital St.Gallen (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Rorschacherstrasse 95
St. Gallen
9007
Switzerland
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
