Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000645459
Ethics application status
Approved
Date submitted
30/11/2007
Date registered
19/12/2007
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
fatigue in patients undergoing chemotherapy for solid tumours
Scientific title
A Randomised Double-Blinded Phase III Study Assessing the Benefits of Amino Acid Supplementation in Patients Receiving Chemotherapy for Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer patients undergoing chemotherapy 2598 0
Condition category
Condition code
Diet and Nutrition 2710 2710 0 0
Other diet and nutrition disorders
Cancer 2711 2711 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
amino acid supplementation: from day 2 of treatment, 4 capsules every morning (before, with or after) breakfast for 12 weeks. If patients are unable to swallow the 4 capsules every morning, then the contents of the capsules are able to be emptied into room temperature water and drunk.
The amino acid mixture is as follows: serine (5.79mg), alanine (37.63mg), glycine (14.93mg), valine (20.03mg), threonine (7.28mg), leucine (17.61mg), proline (13.87mg), isoleucine (17.61mg), asparagine (15.16mg), aspartic acid (11.28mg), phenylalanine (6.65mg), ornithine (6.65mg), glutamic acid (12.5mg), tyrosine (6.65mg), lysine (6.65mg), histidine (6.65mg), cystine (6.65mg), taurine (6.65mg), calcium succinate (1.94mg), magnesium citrate (1.48mg) equivalent ingredient component magnesium (153.9 micrograms), potassium citrate (1.38 micrograms) equivalent ingredient component potassium (498.2mg). Hydrolysed milk protein (75mg).
Intervention code [1] 2331 0
Other interventions
Comparator / control treatment
The placebo tablet contains gelatine
Control group
Placebo

Outcomes
Primary outcome [1] 3608 0
to determine if the use of amino acid supplementation will alter fatigue in patients with cancer receiving chemotherapy
Timepoint [1] 3608 0
after 12 weeks of chemotherapy, then at week 16 (4 weeks post last treatment)
Secondary outcome [1] 6045 0
to determine if the use of amino acid supplementation will alter quality of life
Timepoint [1] 6045 0
baseline, every 2 or 3 weeks (depending on chemotherapy regimen) up to week 16

Eligibility
Key inclusion criteria
1. Histologically or cytoligically proven solid cancer type,
2. Patients who will undergo at least 12 weeks of chemotherapy,
3. radiation therapy may have been given, but there must be a minum of 2 weeks before day 1,
4. 'ECOG - Eastern Cooperative Oncology Group' of 0, 1 or 2,
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. myeloid cancers (excluding muliptle myeloma),
2. receiving chemotherapy once a month,
3. unable to tolerate oral medications at scrrening/baseline,
4. bowel obstruction, lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome,
5. clinically significant cardiac disease as defined by history of symptomatic ventricular arrhythmias, congestive cardiac failure, myocardial infarction within 12 months of study entry, uncontrolled hypertension, unstable angina, 'NYHA - New York Heart Association' grade II or greater,
6. serious uncontrolled infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequential numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 510 0
3144

Funding & Sponsors
Funding source category [1] 2846 0
Self funded/Unfunded
Name [1] 2846 0
A/Prof Gary Richardson
Country [1] 2846 0
Australia
Primary sponsor type
Individual
Name
A/Prof Gary Richardson
Address
Cabrini Hospital
Suite 19,
183 Wattletree Road,
Malvern Victoria 3144
Country
Australia
Secondary sponsor category [1] 2566 0
Commercial sector/Industry
Name [1] 2566 0
Mr William Crothers
Address [1] 2566 0
LMA PacMed Pty Ltd,
Level 1, 263 Mary St., Richmond VIC 3121
Country [1] 2566 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4794 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 4794 0
183 Wattletree Road,
Malvern VIC 3144
Ethics committee country [1] 4794 0
Australia
Date submitted for ethics approval [1] 4794 0
Approval date [1] 4794 0
10/08/2005
Ethics approval number [1] 4794 0

Summary
Brief summary
One of the most commonly reported side effects of chemotherapy is fatigue (tiredness). The impact of fatigue in cancer patients varies from mild (where there is no impact on daily living) to severe (which can interfere with every aspect of daily living). Recently, moderate to severe cancer patient fatigue experiences have been compared to that of patients with chronic fatigue syndrome (CFS) experiencing similar issues (i.e. problems of concentration and motivation, reduced physical activity, emotional health problems and pain).
Clinical trials in a group of CFS patients showed a marked increase in 2 types of amino acids (basic building blocks of proteins), as they were excreted in the urine. This means that proteins in the body were being broken down too quickly. By breaking down the proteins too quickly, specific cell processes may be affected and less energy is available which means that you become tired quicker and maybe for longer periods of time. In another open clinical trial amino acid supplements were given to CFS patients and 75% patients showed a relief in the symptom of fatigue.
Cancer patients, prior to chemotherapy treatment, are provided with basic education and information on how to manage fatigue. However, some patients experience fatigue at a moderate to severe level that needs to be treated by supportive drug therapy by your doctor (i.e. antidepressants for emotional distress & sleep disturbance, blood transfusions for anaemia). When specific causes of fatigue cannot be identified, then other non-medical therapies may be suggested (i.e. introduction of an exercise program).
The aim of this study is to determine whether administering specific amino acid supplements to cancer patients who will be undergoing chemotherapy will reduce the symptom of fatigue.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28222 0
Address 28222 0
Country 28222 0
Phone 28222 0
Fax 28222 0
Email 28222 0
Contact person for public queries
Name 11379 0
Barbara Scher
Address 11379 0
Cabrini Institute,
183 Wattletree Road,
Malvern Vic 3144
Country 11379 0
Australia
Phone 11379 0
03 9508 1669
Fax 11379 0
03 9508 1668
Email 11379 0
[email protected]
Contact person for scientific queries
Name 2307 0
Barbara Scher
Address 2307 0
Cabrini Institute,
183 Wattletree Road,
Malvern Vic 3144
Country 2307 0
Australia
Phone 2307 0
03 9508 1669
Fax 2307 0
03 9508 1668
Email 2307 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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