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fatigue in patients undergoing chemotherapy for solid tumours

A Randomised Double-Blinded Phase III Study Assessing the Benefits of Amino Acid Supplementation in Patients Receiving Chemotherapy for Cancer

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000645459
Enrollment
150
Registered
2007-12-19
Start date
2006-01-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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),

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).

Sponsors

A/Prof Gary Richardson
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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,

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026