Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001247369
Ethics application status
Approved
Date submitted
22/08/2017
Date registered
28/08/2017
Date last updated
3/09/2021
Date data sharing statement initially provided
23/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a Chinese herbal medicine to reduce hot flushes/night sweats in women treated for breast cancer
Scientific title
Randomised, placebo-controlled, double-blind, cross-over, multi-centre study to evaluate the efficacy and safety of a Chinese herbal medicine (Shu Gan Liang Xue Decoction) to alleviate vasomotor symptoms in breast cancer survivors
Secondary ID [1] 292713 0
Nil known
Universal Trial Number (UTN)
U1111-1201-1389
Trial acronym
CHM for hot flushes in breast cancer survivors
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vasomotor symptoms in breast cancer survivors 304461 0
Condition category
Condition code
Cancer 303801 303801 0 0
Breast
Alternative and Complementary Medicine 303814 303814 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled clinical trial with two parallel arms conducted under double-blind and placebo-controlled conditions on 84 participants aged 18 years or more, who have completed their acute stage of breast cancer treatment.
One standard dose (10gr. in granule format) of Chinese herbal medicine, Shu Gan Liang Xue Decoction, dissolved in warm water and taken orally twice per day for 12 weeks, followed by a wash-out period of 4 weeks and then cross-over to the other arm of the trial.
Participants will be asked to mark in their Hot Flush Daily Diary if they miss any doses and will return all unused doses at next visit.
Intervention code [1] 298946 0
Treatment: Other
Comparator / control treatment
One standard dose of Chinese herbal medicine placebo, dissolved in warm water and taken orally twice per day for 12 weeks, followed by a wash-out period of 4 weeks and then cross-over to the other arm of the trial.
Placebo control: placebo will be matched to the herbal medicine in colour, taste, texture and smell. The placebo consists of dextrin 86%, sucrose 5%, caramel 3.6%, citric acid 1.7%, leaf of broadleaf holly 3.5%, gardenia yellow 300 0.1%, sunset yellow 87 0.05%, lemon yellow 85 0.05% = 100%. The interventions will be manufactured in accordance with Therapeutic Goods Administration (TGA) Australia and Good Manufacturing Process (GMP) guidelines.
Control group
Placebo

Outcomes
Primary outcome [1] 303159 0
An in person difference and the difference between the intervention group and the placebo group in hot flush frequency will be compared as measured by the previously validated Hot Flush Daily Diary (Loprinzi)
Timepoint [1] 303159 0
Timepoints: Baseline, Weeks 1-4, Week 8, 12, 16, Weeks 17-20, Week 24, 28, follow up at Week 32 from commencement of trial.
Secondary outcome [1] 338071 0
An in person difference and the difference between the intervention group and the placebo group in changes in scores of severity and average mean score of vasomotor symptoms as measured by the Hot Flush Daily Diary.
Timepoint [1] 338071 0
Timepoints: Baseline, and at Week 1-4, Week 8, 12, 16, Weeks 17- 20, Week 24, 28, follow up at Week 32 after trial commencement.
Secondary outcome [2] 338072 0
Safety measured with Hormone Assays undertaken on blood samples (Oestrogen, Progesterone, Follicle Stimulating Hormone, Luteinizing Hormone)
Timepoint [2] 338072 0
Timepoints: Blood tests at Week 1, 12, 28 from commencement of trial.
.
Secondary outcome [3] 338133 0
An in person difference and the difference between the intervention group and the placebo group in changes in scores of Menopause Specific Quality of Life Questionnaire (MENQoL)
Timepoint [3] 338133 0
Timepoints: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32 from commencement of trial.
Secondary outcome [4] 338134 0
An in person difference and the difference between the intervention group and the placebo group in he change of daily interference as measured by the Hot Flush Related Daily Interference Scale (HFRDIS).
Timepoint [4] 338134 0
Timepoints: Baseline, Week 1, 4, 8, 12, 16, 20, 24, 28, 32 from commencement of trial.
Secondary outcome [5] 338135 0
Safety measured with Adverse Effects Log.
The formula herbs are all approved by the TGA, Australia. Side-effects are minimal and may include minor gastro-intestinal upset or bloating.
Participants will write down any adverse effects they experience between visits that may or may not be related to the intervention. At each visit they will also be quizzed as to any adverse effects.
Timepoint [5] 338135 0
Timepoints: Week 4, 8, 12, 20, 24, 28 from commencement of trial.
Secondary outcome [6] 338136 0
Safety measured with blood tests for Hepatic and Renal Function
Timepoint [6] 338136 0
Timepoints: Blood tests at week 1, 12, 28 from commencement of trial.
Secondary outcome [7] 338137 0
Safety measured with Tamoxifen Metabolite testing. This is an added precaution to ensure that the Chinese herbal medicine does not interfere with the metabolism of Tamoxifen. It will be conducted in a small cohort from Liverpool Hspital (<12).
Tests will be carried out at the same time as other blood tests to reduce burden on participants.
Timepoint [7] 338137 0
Timepoints: Week 1, 12, 28 from commencement of trial.. Time of last dose of tamoxifen and Chinese herbal medicine noted on pathology form.
Secondary outcome [8] 338138 0
Safety measured with a liquid biopsy to detect whether CTCs/ESR1 is present. This as an added precaution and may help pave the way for a larger clinical trial.
This test will be conducted in a small cohort from Liverpool Hospital only and blood for this testwill be collected at the same time as other blood tests to reduce participant burden (<20).
This test will determine the proportion of participants who are CTCs/ESR1 positive and may determine whether the Chinese herbal medicine changes levels of CTCs/ESR1..
Participants will not be given the results of this test as it is still in an early phase and the reliability of the results is unknown.
Timepoint [8] 338138 0
Timepoints: Week 1, 12, 28 from trial commencement.

Eligibility
Key inclusion criteria
1)Female, over 18 years, diagnosed with Stage 1-3 breast cancer, 2) completed surgery, chemotherapy and/or radiation. 3) If prescribed an estrogen-blocking medication i.e. tamoxifen or aromatase inhibitor stable for > 2 months prior to the study and unlikely to be changing estrogen-blocking medication during the study. 4) Protocol defined adequate hepatic and renal function. 5) Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if they have 1) poorly controlled hypertension, hypothyroidism or diabetes mellitus 2) hyperthyroidism 3) use of Hormone Replacement Therapy (HRT) - washout period 8 weeks 4)Unwilling to refrain from other remedies for hot flushes during study 5) pregnant or breast-feeding 9) use on blood-thinning medication 10) any other chronic condition deemed inappropriate by the clinician for the trial 11) Lack of, or withdrawal of informed consent. 12) Participation in another 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)
Allocation concealment will be conducted centrally by a computer generated system. .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur through pre-arranged blinded sequences of supplies of treatment granules by a officer of the National Institute of Complementary Medicine. An allocation and dispensing sequence numbers will be available for the trial participants in a uniform 1:1 ratio using a computer generated permuted block sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was calculated in consulation with a professional statistician at Western Sydney University. Allowing for a 25% drop in frequency of hot flushes due to placebo effect we define minimum clinically important improvement to be twice the size of the placebo effect (50% decrease in frequency). We expect the mean frequency to be 6 with a standard deviation of 4 at baseline and estimate the required sample size is 48 to produce 80% power to detect the difference between 25% decrease (placebo) and 50% decrease (treatment), using a two-sided matched pairs t-test with 5% significance level. Assuming an attrition rate of 30%, based on earlier research, a target sample of 84 participants is required.
Statistical analysis will be SPSS based. The primary analysis is intention-to-treat with baseline frequency and treatment order as predictors.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
4/09/2017
Actual
22/01/2018
Date of last participant enrolment
Anticipated
16/11/2018
Actual
16/11/2018
Date of last data collection
Anticipated
11/04/2019
Actual
11/04/2019
Sample size
Target
84
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8845 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 8846 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 8847 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 16980 0
2170 - Liverpool
Recruitment postcode(s) [2] 16981 0
2200 - Bankstown
Recruitment postcode(s) [3] 16982 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 297344 0
University
Name [1] 297344 0
Western Sydney University
Country [1] 297344 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 296326 0
None
Name [1] 296326 0
Address [1] 296326 0
Country [1] 296326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298444 0
South West Sydney Local Health District
Ethics committee address [1] 298444 0
Ethics committee country [1] 298444 0
Australia
Date submitted for ethics approval [1] 298444 0
23/01/2017
Approval date [1] 298444 0
15/05/2017
Ethics approval number [1] 298444 0
HREC/17/LPOOL/25

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

Contacts
Principal investigator
Name 77114 0
Ms Dianna Porter
Address 77114 0
Building 22, Campbelltown Campus, Western Sydney University, Locked Bag 1797, Penrith NSW 2751
Country 77114 0
Australia
Phone 77114 0
+ 61 415455033
Fax 77114 0
Email 77114 0
[email protected]
Contact person for public queries
Name 77115 0
Dianna Porter
Address 77115 0
Building 22,, Campbelltown Campus, Western Sydney University Locked Bag 1797, Penrith NSW 2751
Country 77115 0
Australia
Phone 77115 0
+61 415455033
Fax 77115 0
Email 77115 0
[email protected]
Contact person for scientific queries
Name 77116 0
Xiaoshu Zhu
Address 77116 0
Building 24, Campbelltown Campus, Western Sydney University
Locked Bag 1797, Penrith NSW 2751
Country 77116 0
Australia
Phone 77116 0
+61 2 4620 3338
Fax 77116 0
Email 77116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7738Informed consent form  [email protected]
7739Ethical approval  [email protected]
7740Study protocol  [email protected]
7741Statistical analysis plan  [email protected]



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.