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Simple solutions to gastro-intestinal symptoms in chemotherapy patients

Can upper gastric chemotherapy symptoms be predicted by taste genetics and will mouth wash solutions of water, salt, sodium bicarbonate, sugar, ginger or peppermint water improve taste changes, nausea or vomiting in patients receiving chemotherapy of cyclophosphamide or 5-FU

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000924550
Enrollment
32
Registered
2015-09-04
Start date
2016-03-01
Completion date
2018-02-05
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

The primary purpose of this study is to determine whether simple mouthwashes can decrease symptoms of poor appetite, taste changes, nausea and vomiting due to chemotherapy. The study also aims to predict which patients will develop the most symptoms based on genetic and taste bud counting tests. Who is it for? You may be eligible to join this study if you are aged 18-85 years and due to receive intravenous chemotherapy of cyclophosphamide or 5-FU. Study details Prior to the first cycle of chemotherapy, genetic characteristics of each participant's taste will be tested using saliva samples, and the number of taste buds on the tongue will be counted. After 2 cycles of chemotherapy, participants will be asked to rate their symptoms of appetite, taste changes, nausea and vomiting. Patients with these symptoms will then test 6 different simple mouthwashes, including salt, sodium bicarbonate, sugar, ginger and peppermint oil, in a random order for 1 day per mouthwash. Patients will be asked to rate the effectiveness of each of the mouthwashes in reducing symptoms via questionnaire. It is hoped that these simple mouthwashes may be able to minimise symptoms, thus improving chemotherapy patient well-being, potentially increasing oral intake and thereby improving nutritional status.

Interventions

At base line before chemotherapy commmenced genetic test strips will be used to screen for taste sensitivities Genetic taste test strips will be used to screen for genetically inherited taste recognition thresholds using taste testing strips which are impregnated with either 30mg thiourea, 30mg phenylthiocarbamide (PTC), or 30mg sodium benzoate. Participants were asked to trial each taste test strip in a random order by applying a strip to their moistened tongue and reporting whether it had no t

At base line before chemotherapy commmenced genetic test strips will be used to screen for taste sensitivities Genetic taste test strips will be used to screen for genetically inherited taste recognition thresholds using taste testing strips which are impregnated with either 30mg thiourea, 30mg phenylthiocarbamide (PTC), or 30mg sodium benzoate. Participants were asked to trial each taste test strip in a random order by applying a strip to their moistened tongue and reporting whether it had no taste or tasted bitter, salty, sour, sweet, or any other taste. Patients will be classified as non-tasters with no taste reported, tasters when a recognisable taste is identified, and hyper-tasters if a strong taste was elicited. Number of taste buds counted by placing a drop of blue food colouring on tip of dry tongue A 6mm round hole in filter paper placed over the area dyed and the number of papillae counted within this space. Patients will be asked about their symptoms during cycle 2. Those reporting symptoms will be asked to trial mouth rinses during cycle 3 when symptoms are reported to be greatest. Mouth washes of various common oral fluids will be trialled for 12 hours in random order as often as patient requires but at least twice for six consecutive days with overnight wasout periods. They will complete a questionaire daily to see which mouth washes improve taste and symptoms in chemotherapy. a)Distilled cold water 500ml b)Salt 5 g in 500ml cold water c)Sodium bicarbonate 5 g in 500ml cold water d)Sugar 25g in 500ml cold water e)Ginger 2 gram in 500ml cold water f) Peppermint oil 0.2 ml in 500ml coldwater Monitoring for adherence is by questionaire completion and container return.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Competent patients aged 18-85 to receive intravenous chemotherapy of cyclophosphamide on regimens AC, TC, AC-T or FEC-D or 5-FU on regimens Modified FOLFOX6 or modified de gramont

Exclusion criteria

Unable or unwilling to sign the consent form Patients with head and neck cancer Patients having concurrent radiotherapy Patients already receiving chemotherapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026