Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001330538p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2024
Date registered
1/11/2024
Date last updated
1/11/2024
Date data sharing statement initially provided
1/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effects of standardised GINGER root powder on chemotherapy-induced nausea and vomiting using body surface gastric MAPping (The Ginger-MAP Study)
Scientific title
The effect of low dose versus high dose ginger supplementation compared to standard care (no ginger) on gastric motility (measured by body surface gastric mapping) in patients receiving chemotherapy classified as at moderate to high risk of emesis.
Secondary ID [1] 313075 0
Nil
Universal Trial Number (UTN)
Trial acronym
The Ginger-MAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 335311 0
chemotherapy-induced nausea and vomiting 335312 0
Condition category
Condition code
Cancer 331885 331885 0 0
Any cancer
Diet and Nutrition 331887 331887 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 331888 331888 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 331889 331889 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will occur at one single time point and the study duration is for one single calendar day.

Intervention Groups 2 and 3 will receive standard care (including prescribed anti-emetic medication) in addition to a highly refined, standardised ginger root powder supplement in capsule form for oral consumption as a single dose (one time only) at the commencement of chemotherapy infusion. The ginger extract is manufactured by an independent company that will have no involvement in the study. The 300mg ginger root powder capsule will be standardised to contain 7% bioactive compounds (gingerols and shogaols).

Group 2 (low dose ginger) will receive one capsule (300mg of ginger root, 21mg of bioactive compounds [gingerols and shogaols]).

Group 3 (high dose ginger) will receive two capsules (600mg of ginger root, 42mg of gingerols/shogaols).

All participants will be required to have fasted (food and drinks) for 4 hours prior to the test commencing (water is okay). All participants will be given a meal to consume after 30-minutes of baseline data has been captured. This meal will be standardised to contain similar energy and macronutrient contents and will meet any special dietary requirements or preferences of participants.

Adherence to supplement consumption will be noted by the investigator who administered the intervention and test. Adherence will be noted as the number of supplement capsules consumed as per the protocol (0, 1, or 2 capsules).
Intervention code [1] 329632 0
Treatment: Other
Comparator / control treatment
Group 1 will receive standard care, whereby they will not receive an intervention. Anti-emetic medication prescribed by the medical team will be permitted during the trial.

Group 4 will be matched healthy controls (not receiving chemotherapy for cancer). Healthy controls will receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 339500 0
Gastric Alimetry rhythm index (GA-RI)
Timepoint [1] 339500 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable); reading taken from 30-minute test duration. T1: postprandial, during chemotherapy infusion (if applicable); reading taken from 4-6 hour test duration.
Primary outcome [2] 339504 0
Fed:fasted amplitude ratio (ff-AR)
Timepoint [2] 339504 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable); reading taken from 30-minute test duration. T1: postprandial, during chemotherapy infusion (if applicable); reading taken from 4-6 hour test duration.
Secondary outcome [1] 440212 0
Gastric dominant frequency
Timepoint [1] 440212 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable); reading taken from 30-minute test duration. T1: postprandial, during chemotherapy infusion (if applicable); reading taken from 4-6 hour test duration.
Secondary outcome [2] 440213 0
Principal gastric frequency
Timepoint [2] 440213 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable); reading taken from 30-minute test duration. T1: postprandial, during chemotherapy infusion (if applicable); reading taken from 4-6 hour test duration.
Secondary outcome [3] 440214 0
BMI-adjusted gastric amplitude
Timepoint [3] 440214 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable); reading taken from 30-minute test duration. T1: postprandial, during chemotherapy infusion (if applicable); reading taken from 4-6 hour test duration.
Secondary outcome [4] 440215 0
Nausea severity score
Timepoint [4] 440215 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [5] 440216 0
Heartburn severity score
Timepoint [5] 440216 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [6] 440217 0
Stomach-burn severity score
Timepoint [6] 440217 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [7] 440218 0
Upper gut pain severity score
Timepoint [7] 440218 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [8] 440219 0
Bloating severity score
Timepoint [8] 440219 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [9] 440220 0
Excessive fullness severity score
Timepoint [9] 440220 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [10] 440221 0
Vomiting frequency
Timepoint [10] 440221 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [11] 440222 0
Reflux frequency
Timepoint [11] 440222 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [12] 440223 0
Belching frequency
Timepoint [12] 440223 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).
Secondary outcome [13] 440225 0
Alimetry Gut-brain Wellbeing total score
Timepoint [13] 440225 0
T0: baseline/fasting, immediately prior to chemotherapy commencing (if applicable). T1: postprandial, during chemotherapy infusion (if applicable).

Eligibility
Key inclusion criteria
People undergoing chemotherapy (Groups 1-3):
Inclusion criteria:
• Moderate to high risk of emesis (a score of 13 or more on the CINV Risk Tool).
• Scheduled to undergo intravenous chemotherapy for any type of cancer.
• Naïve and non-naïve to chemotherapy.
• Aged 18 years or above.
• Body Mass Index (BMI) <35 kg/m2 (as the Gastric Alimetry results may be unreliable for patients with BMI > 35 kg/m2).
• Willing to adhere to controlled background lifestyle (no other ginger, no alcohol, no use of self-prescribed nausea therapiesa within 48 hours of the test).
• Willing to not have any food and drinks other than water for 4 hours or more before the test.
• Willing to not smoke or vape during the test period.
• Able to remain in a relaxed, reclined position for the test duration.

Matched healthy Controls (Group 4):
Inclusion criteria:
• Age and sex matched to intervention groups 1-3.
• BMI <35 kg/m2 (as the Gastric Alimetry results may be unreliable for patients with BMI > 35 kg/m2).
• Willing to adhere to controlled background lifestyle (no ginger, alcohol, or use of self-prescribed nausea therapies) from within 48-hours prior to the test.
• Willing to not have any food and drinks other than water for 4 hours or more before the test and to not smoke or vape during the test period.
• Able to remain in a relaxed, reclined position for the test duration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People undergoing chemotherapy (Groups 1-3):
Exclusion criteria:
• Severe cognitive impairment preventing ability to fully understand the purpose of the study, adhere to the study procedures, and complete data collection forms.
• Pregnant or breastfeeding women.
• High risk of abnormal or altered gastric motility (e.g., medications [e.g., opiates, sedatives, antispasmodics] or electrolyte imbalances causing gastrointestinal symptoms, cancer of the gastrointestinal tract and ancillary organs [mouth, oesophagus, stomach, intestine, colon, colorectal, rectal, pancreas, liver, gall bladder, bile duct, or other gastrointestinal cancer e.g., head and neck cancer], diabetes, delayed gastric emptying [other reasons], brain cancer and metastases, intestinal obstruction).
• Unable to receive gastric motility assessment via the Gastric Alimetry (e.g., history of skin sensitivity to adhesives or hydrogels on any part of the body; and skin conditions, fragile skin, wounds, abrasions, infection, or inflammation in the abdominal skin areas intended for Array placement).
• Unable to consume test product (swallowing concerns, allergic reactions, etc).
• Concurrent radiotherapy, a known risk factor for nausea and vomiting.
• Severe thrombocytopenia (platelets <50 x 10^9/L).
• Participants with other factors deemed by the Investigators as not suitable for the trial.

Matched healthy Controls (Group 4):
Exclusion criteria:
• Severe cognitive impairment preventing ability to fully understand the purpose of the study, adhere to the study procedures, and complete data collection forms.
• Pregnant or breastfeeding women.
• High risk of abnormal or altered gastric motility (e.g., medications [e.g., opiates, sedatives, antispasmodics] or electrolyte imbalances causing gastrointestinal symptoms, cancer of the gastrointestinal tract and ancillary organs [pancreas, liver, etc], diabetes, delayed gastric emptying [other reasons], brain cancer and metastases, intestinal obstruction).
• Unable to receive gastric motility assessment via the Gastric Alimetry (e.g., history of skin sensitivity to adhesives or hydrogels on any part of the body; and skin conditions, fragile skin, or wounds, abrasions, infection, or inflammation in the abdominal skin areas intended for Array placement).
• Any other medical condition or routine use of medications, recreational drugs, tobacco, or vaping.
• Moderate to severe gastrointestinal symptoms (score of 3 or more on any question of the gastrointestinal system rating scale [GSRS]).
• Participants with other factors deemed by the Investigators as not suitable for the trial.

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)
Group allocation will be concealed from participants with use of central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
via REDCap web-based software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43251 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 317516 0
University
Name [1] 317516 0
Queensland University of Technology
Country [1] 317516 0
Australia
Funding source category [2] 317520 0
University
Name [2] 317520 0
Queensland University of Technology Early Career Researcher Ideas Grant
Country [2] 317520 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319822 0
None
Name [1] 319822 0
None
Address [1] 319822 0
Country [1] 319822 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316230 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316230 0
Ethics committee country [1] 316230 0
Australia
Date submitted for ethics approval [1] 316230 0
30/09/2024
Approval date [1] 316230 0
Ethics approval number [1] 316230 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137222 0
Dr Megan Crichton
Address 137222 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137222 0
Australia
Phone 137222 0
+61731386322
Fax 137222 0
Email 137222 0
[email protected]
Contact person for public queries
Name 137223 0
Megan Crichton
Address 137223 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137223 0
Australia
Phone 137223 0
+61731386322
Fax 137223 0
Email 137223 0
[email protected]
Contact person for scientific queries
Name 137224 0
Megan Crichton
Address 137224 0
Queensland University of Technology, Cancer and Palliative Care Outcomes Centre, 60 Musk Avenue, Kelvin Grove QLD 4059, Australia
Country 137224 0
Australia
Phone 137224 0
+61731386322
Fax 137224 0
Email 137224 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification.

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator (Dr Megan Crichton, Queensland University of Technology, [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.