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Trial registered on ANZCTR


Registration number
ACTRN12623000193673
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
23/02/2023
Date last updated
14/06/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of acute exercise on endocannabinoid and mood responses in adults with cancer: A pilot study
Scientific title
Effect of acute exercise on endocannabinoid and mood responses in adults with cancer: A pilot study
Secondary ID [1] 308871 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 328859 0
Condition category
Condition code
Cancer 325856 325856 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute Exercise (30 min) will be performed immediately following the control condition:
Each participant will perform one acute aerobic exercise bout on self-selected equipment modality (Precor treadmill, Precor upright cycle or Monark RT2 recumbent cycle ergometer) and aim to attain a moderate intensity (i.e. 64-76% of age-predicted maximal heart rate (HRmax=208 – (0.7 × age)) within 5 min (warm-up) and then maintain this HR intensity range (64-76% of HRmax) for 20 minutes continuously. For the final 5 min, participants will perform a cool-down with the aim of reducing heart rate to below 60% of by the end of the 30 min condition. Rating of perceived exertion (RPE), heart rate and SpO2 will be collected at 1 min intervals throughout the exercise condition. Heart rate will be measured via a Polar H9/H10 heart rate monitor (Polar Electro Oy, Professorintie 5, Fi-90440 Kempele, Finland) and Oxygen saturation will be recorded via iHealth pulse oximeter. Blood pressure will be collected every 5 min via a manual Welsh Allyn DS66 trigger aneroid sphygmomanometer using the non-cannulated arm unless contraindicated (e.g. lymphedema risk). Exercise does not stop for the collection of any data. Recommended criteria for prematurely terminating the exercise condition will be adhered to, as defined by the American College of Sports Medicine. At the end of the exercise bout, the third and final blood sample being collected and then the ten VAS scales will be re-assessed, followed by a question asking participants whether they had experienced a ‘Runner’s high’ (Yes / No / I don’t know), as implemented in a previous trial.
Intervention code [1] 325314 0
Rehabilitation
Comparator / control treatment
Seated Rest (30 min):
Participants will remain seated and reading a book or magazine of their choice for a 30-minute period. Mobile phones will be placed on silent and placed out of reach of the participant. Heart rate will be measured via Polar H/9/10 heart rate monitor (Polar Electro Oy, Professorintie 5, Fi-90440 Kempele, Finland). Oxygen saturation will be recorded via iHealth pulse oximeter. Blood pressure will be collected at the beginning of the seated rest condition and at 5 min intervals thereafter using stethoscope and a manual Welsh Allyn DS66 trigger aneroid sphygmomanometer. All measurements will be performed by an exercise physiologist trained in the procedure. The VAS scales will be collected immediately after the final round of observations (i.e. heart rate, SpO2 and blood pressure) followed by the second blood sample.
Control group
Active

Outcomes
Primary outcome [1] 333684 0
N-arachidonoylethanolamine (AEA; aka. Anandamide) will be assessed by liquid chromatography-mass spectrometry (LC-MS) of plasma samples.
Timepoint [1] 333684 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Primary outcome [2] 333686 0
2-Arachidonoylglycerol (2-AG) will be assessed by liquid chromatography-mass spectrometry (LC-MS) of plasma samples.
Timepoint [2] 333686 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [1] 417944 0
Palmitoylethanolamide (PEA) will be assessed by liquid chromatography-mass spectrometry (LC-MS) of plasma samples.
Timepoint [1] 417944 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [2] 417945 0
Oleoylethanolamide (OEA) will be assessed by liquid chromatography-mass spectrometry (LC-MS) of plasma samples.
Timepoint [2] 417945 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [3] 417946 0
stearoylethanolamide (SEA) will be assessed by liquid chromatography-mass spectrometry (LC-MS) of plasma samples.
Timepoint [3] 417946 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [4] 417949 0
Visual Analog Scales (VAS) for Pain.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [4] 417949 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [5] 417951 0
Experience of a Runner's high:
Participants will be asked whether they had experienced a ‘Runner’s high’ (Yes / No / I don’t know).
Timepoint [5] 417951 0
Post Exercise Condition
Secondary outcome [6] 418598 0
Visual Analog Scales (VAS) for Nausea.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [6] 418598 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [7] 418600 0
Visual Analog Scales (VAS) for Anger.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [7] 418600 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [8] 418601 0
Visual Analog Scales (VAS) for Sadness.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [8] 418601 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [9] 418602 0
Visual Analog Scales (VAS) for Happiness.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [9] 418602 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [10] 418603 0
Visual Analog Scales (VAS) for Energy.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [10] 418603 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [11] 418604 0
Visual Analog Scales (VAS) for Fatigue.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [11] 418604 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [12] 418605 0
Visual Analog Scales (VAS) for Anxiety.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [12] 418605 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [13] 418606 0
Visual Analog Scales (VAS) for Euphoria.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [13] 418606 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [14] 418607 0
Visual Analog Scales (VAS) for Depression.
Participants will place a vertical slash mark on a 100mm horizontal line ranging from 0 to 100 indicating their current emotional state.
Timepoint [14] 418607 0
Baseline, Post Seated Rest Condition, Post Exercise Condition
Secondary outcome [15] 418859 0
Rating of Perceived Exertion (RPE) will be collected using a 6-20 point Borg Scale
Timepoint [15] 418859 0
During exercise condition (1 min intervals)
Secondary outcome [16] 418860 0
Heart Rate will be assessed by heart rate monitor (Polar Electro Oy, Professorintie 5, Fi-90440 Kempele, Finland)
Timepoint [16] 418860 0
During seated rest and exercise conditions (1 min intervals)
Secondary outcome [17] 418862 0
Oxygen saturation will be collected using iHealth pulse oximeter
Timepoint [17] 418862 0
During seated rest and exercise conditions (1 min intervals)
Secondary outcome [18] 418863 0
Blood pressure (manual)
Timepoint [18] 418863 0
During seated rest and exercise conditions (5 min intervals)

Eligibility
Key inclusion criteria
Cancer patients: Adults (18 years and older) commenced chemotherapy treatment for a non-haematological cancer with a 2 or 3-weekly protocol; Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, medical approval of the treating oncologist (via email), sufficient English to provide consent and complete study procedures.

Healthy controls: Adults (>18 years); gender-, age- (+/-5 years maximum) and BMI-matched (+/-3.5 kg/m2 maximum) to the recruited cancer patient; no history of systemic cancer treatment; no history of cardiac, metabolic, pulmonary, neurological and/or uncontrolled risk factors; sufficient English to provide consent and complete study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• currently using cannabis regularly, for any reason
• any use of cannabis or cannabis products (e.g. CBD oil) within the previous 72 hours
• vigorous exercise or use of complementary therapies such as acupuncture, massage, reflexology, yoga or mindfulness training within 24 hours of the research session
• currently using anti-depressant and/or anxiolytic medication
• continuous use of steroids (i.e. outside of their standard chemotherapy protocol in cancer patients)
• presenting with any absolute or relative contraindication to clinical exercise testing, as defined by the American College of Sports Medicine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
1/05/2023
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23900 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 39384 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 313091 0
Charities/Societies/Foundations
Name [1] 313091 0
The SurFebruary Cancer Research Fund
Country [1] 313091 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road, Camperdown NSW 2050, Australia
Country
Australia
Secondary sponsor category [1] 314796 0
None
Name [1] 314796 0
None
Address [1] 314796 0
None
Country [1] 314796 0
Other collaborator category [1] 282534 0
University
Name [1] 282534 0
Western Sydney University
Address [1] 282534 0
Locked Bag 1797 Penrith NSW 2751
Country [1] 282534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312336 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 312336 0
390 Victoria Street, Darlinghurst, NSW 2010, Australia
Ethics committee country [1] 312336 0
Australia
Date submitted for ethics approval [1] 312336 0
19/01/2022
Approval date [1] 312336 0
14/04/2022
Ethics approval number [1] 312336 0
2022/ETH00098

Summary
Brief summary
This study aims to compare the effect of a single bout of exercise on endocannabinoid (eCB) and affective (mood) responses in adults with cancer currently receiving chemotherapy treatment versus their healthy peers, and to evaluate relationships between eCB and mood responses to exercise.
Who is this study for?
You may be eligible for this study if you are a cancer patient aged 18 or older, and currently receiving chemotherapy treatment; and if you are an apparently healthy adult (age 18+) .
Study details
All participants will engage in a single testing session involving seated rest (30 min) followed by a moderate exercise bout on treadmill or exercise cycle (30 min). Participants will be asked to fill in mood surveys and provide blood samples before and after the seated rest and exercise conditions.
It is hoped that findings from this study will help inform future trials investigating the benefits and barriers to exercise in cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124302 0
A/Prof Judith Lacey
Address 124302 0
Chris O'Brien Lifehouse Living Room
119-143 Missenden Road, Camperdown NSW 2050
Australia
Country 124302 0
Australia
Phone 124302 0
+610285140038
Fax 124302 0
Email 124302 0
judith.lacey@lh.org.au
Contact person for public queries
Name 124303 0
Dr Justine Stehn
Address 124303 0
Chris O'Brien Lifehouse Living Room
119-143 Missenden Road, Camperdown NSW 2050
Australia
Country 124303 0
Australia
Phone 124303 0
+610285140038
Fax 124303 0
Email 124303 0
justine.stehn@lh.org.au
Contact person for scientific queries
Name 124304 0
Dr Justine Stehn
Address 124304 0
Chris O'Brien Lifehouse Living Room
119-143 Missenden Road, Camperdown NSW 2050
Australia
Country 124304 0
Australia
Phone 124304 0
+610285140038
Fax 124304 0
+610285140038
Email 124304 0
justine.stehn@lh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A unique study number will be assigned to the patient to maintain the participant’s privacy. The trial number will only be linked to the patient's details at the institution and will not be sent offsite. The study data will be kept in coded form and will be stored in a computerised database located at COBLH. The investigators will maintain a confidential participant identification list that allows the unambiguous identification of each participant. Consent to transfer data is sought via the Patient Information and Consent Form. No identifying information will be published. It is also understood that the recipients will treat the data in accordance with all applicable privacy legislation and local policies and that recipients will not use of disclose the information outside the parameters of the agreement between them and the institution. All data (including personal data) obtained will be treated as confidential. The personal data will be stored at each study site in encrypted electronic and/or paper form and will be password protected or secured in a locked room to ensure that only authorised study staff have access. Only coded blood samples will be transferred off site for analysis at the National Institute of Complementary Medicine (Westmead, NSW). Data is de-identified with each participant assigned a study code (except for personal information). Any identifying data (name, email address, phone number) is stored in a password-protected program (REDCap). Only the study investigators will have access to completed consent data and research data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18237Study protocol    385311-(Uploaded-03-02-2023-13-51-26)-Study-related document.docx
18238Ethical approval    385311-(Uploaded-03-02-2023-13-57-08)-Study-related document.pdf
18239Informed consent form    385311-(Uploaded-03-02-2023-13-57-08)-Study-related document.doc



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.