None listed
Conditions
Brief summary
The purpose of this research is to investigate the effects of a rice bran arabinoxylan compound (RBAC) as a nutritional supplement on the health-related quality of life (QoL) of cancer patients. Who is it for? You may be eligible for this study if you are between 18 and 70 years old, diagnosed with any solid organ cancer, and currently undergoing active treatment. Study details Participants in this study will be randomised by chance into two groups. One group will consume 3g per day of the study compound (RBAC) packed in sachets for 24 weeks. The other group will take an inactive placebo treatment for the same period. The assigned intervention will be in addition to your usual cancer care. As part of the study, all participants will complete questionnaires, be weighed and provide blood and stool samples. Results from this research can improve the understanding of the effect of RBAC during cancer treatment, inform the planning of a larger trial, and supply data to validate the immuno-therapeutic benefits of RBAC.
Interventions
The intervention is an oral supplement of rice bran arabinoxylan compound (RBAC) powder packed in plastic sachets. The dosage is 3g per day for a duration of 24 weeks. Each RBAC sachet contains 1g of the active ingredient with excipients of microcrystalline cellulose (500mg), dextrin (200mg), corn starch (260mg), and tricalcium phosphate (40mg). The participants will take two sachets in the morning and one sachet in the evening during or after meals. The participants are to thoroughly mix the contents of the sachets into half a glass (approximately 125 ml) of water and drink it right away. This mode of administration makes the dry powder easy to swallow. To ensure adherence, the study coordinator will repeatedly provide instructions about taking supplement sachets including timing, storage, and what to do in the event of a missed dose during initial dispensing and every subsequent visit. The participants are to return unused sachets at each follow-up visit to be counted and recorded for compliance assessment. Participants will continue their active cancer treatment and medications as instructed by their treating oncologists. However, all concomitant medications used during the study will be recorded and updated at baseline and during each visit.
Sponsors
Study design
Eligibility
Inclusion criteria
Adult patient with informed consent, diagnosed with Stage II-IV solid organ cancers, maintains adequate major organ function (bone marrow, liver, and kidneys), currently undergoing active systemic therapies.
Exclusion criteria
Existing mental health conditions that may impede the ability in providing consent; Inability to complete QoL questionnaire with minimal assistance; Pregnant, lactating, or has plan to get pregnant during the period of the trial; Active or prior documented autoimmune or inflammatory disorders within the last five years, except for vitiligo or alopecia, stable hypothyroidism on hormone replacement, and any chronic skin condition that does not require systemic therapy.