Tamoxifen-related endocrine symptoms in Chinese patients with breast cancer
| ISRCTN | ISRCTN10773849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10773849 |
- Submission date
- 25/09/2019
- Registration date
- 27/09/2019
- Last edited
- 19/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is the most prevalent cancer in women in Hong Kong and worldwide. After treatment such as surgery and chemotherapy, disease recurrence remains a significant concern. Nowadays, a common practice to prevent recurrence is to have women on adjuvant tamoxifen, a hormonal therapy, for 5 years. The relapse rate at 5 years for patients who adhere to adjuvant tamoxifen is significantly lower than for those women who discontinue the drug. However, among patients who receive adjuvant tamoxifen treatment, individual responses are highly variable. These variable responses include the type, frequency and severity of endocrine symptoms and reduced tamoxifen adherence, which ultimately affect the cancer recurrence rate. Polymorphisms (genetic variations) in some genes involved in the metabolism of tamoxifen are likely to influence these detrimental responses to tamoxifen. This study aims to characterize the genetic polymorphisms of tamoxifen metabolism-associated genes in Chinese women with breast cancer and to explore the inter-relationships between genetic polymorphisms, endocrine symptoms, and adherence to tamoxifen that could affect the effectiveness of treatment.
Who can participate?
Chinese women with breast cancer treated with surgery and chemotherapy and started on tamoxifen within the past month
What does the study involve?
A questionnaire consisting of demographics, health status details, assessment of endocrine symptoms and drug adherence is completed at the start of the study and after 3, 6, 9 and 12, 15, and 18 months by phone interview. At 12 and 18 months, information on breast cancer recurrence is collected. A saliva sample is also collected from the participants at the start of the study to test for genetic polymorphisms. Participants keep a medication log book to record their intake of tamoxifen, supplements, Chinese herbal medicine, and other medications on a daily basis. The surveys are completed anonymously.
What are the possible benefits and risks of participating?
There are no risks and benefits expected from the study.
Where is the study run from?
Chinese University of Hong Kong and Prince of Wales Hospital (Hong Kong)
When is the study starting and how long is it expected to run for?
November 2016 to August 2021
Who is funding the study?
Chinese University of Hong Kong (Hong Kong)
Who is the main contact?
Prof. Carmen Wing Han Chan
whchan@cuhk.edu.hk
Contact information
Scientific
Room 732, Esther Lee Buidling
The Chinese University of Hong Kong
Hong Kong
-
Hong Kong
| Phone | +852 (0)39436218 |
|---|---|
| whchan@cuhk.edu.hk |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Identification of predictive biomarkers for tamoxifen-related endocrine symptoms and drug adherence based on genetic polymorphisms in Chinese patients with breast cancer: a prospective pilot study |
| Study objectives | 1. There is a relationship between the severity of tamoxifen-induced endocrine symptoms and allelic variations in tamoxifen metabolism-related genes 2. Patients with more severe endocrine symptoms (psychological, vasomotor, somatic or sexual) are less likely to adhere to tamoxifen |
| Ethics approval(s) | Approved 01/12/2016, The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; Tel: +852 (0)35053935; Email: crec@cuhk.edu.hk), Approval #2016.554 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | This prospective cohort study will recruit patients from the Department of Clinical Oncology in Prince of Wales Hospital in Hong Kong. Self-reported endocrine symptoms and the saliva of patients will be collected at enrolment. At 3, 6, 9, 12, 15, 18 months after enrolment, data on symptoms and drug adherence will be collected by phone interview using the same measures. Data collection will stop at 18 months because symptoms of tamoxifen therapy appear early and are worst during the first 12 months after the initiation of treatment. Patients’ saliva will be collected during enrolment for the single nucleotide polymorphism (SNP) evaluation of genes associated with drug metabolism enzymes and transporters. |
| Intervention type | Other |
| Primary outcome measure | Endocrine symptoms measured using the Greene Climacteric Scale (GCS) and the Functional Assessment of Cancer Therapy-Endocrine subscale (FACT–ES) questionnaire (version 4) at enrolment, 3, 6, 9, 12, 15 and 18 months |
| Secondary outcome measures | Drug adherence measured using the Modified Medication Adherence Report Scale (MMARS) and the Medication Possession Ratio (MRP) at 3, 6, 9, 12, 15 and 18 months |
| Overall study start date | 01/11/2016 |
| Completion date | 31/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Chinese women with histologically confirmed estrogen receptor-positive, stage I–III, primary invasive breast cancer 2. Treated with definitive surgery and/or chemotherapy and started on tamoxifen (20 mg daily) within the past month |
| Key exclusion criteria | 1. Patients with other primary malignancies within the last 5 years 2. Patients who are pregnant or are planning to become pregnant, lactating 3. Treated with investigational drugs within the 4 weeks prior to enrolment 4. Not able to provide informed consent |
| Date of first enrolment | 23/12/2016 |
| Date of final enrolment | 31/08/2020 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Prince of Wales Hospital, Shatin, New Territories
Hong Kong
-
Hong Kong
Sponsor information
University/education
The Nethersole School of Nursing
6/F, Esther Lee Buidling
Hong Kong
-
Hong Kong
| Phone | +852 (0)39438174 |
|---|---|
| nursing@cuhk.edu.hk | |
| Website | http://www.nur.cuhk.edu.hk/home-page/ |
"ROR" |
https://ror.org/00t33hh48 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The Chinese University of Hong Kong, 香港中文大学, CUHK
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 31/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journals at 6-12 months after the data collection was ended. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as the researchers planned to have the data for research and publication use only. They will keep the dataset in their computer with encryption. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/02/2020 | 19/08/2022 | Yes | No |
Editorial Notes
19/08/2022: Publication reference added.
20/10/2020: The recruitment end date was changed from 31/07/2021 to 31/08/2020.
04/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2020 to 31/07/2021.
2. The overall end date was changed from 31/08/2020 to 31/08/2021.
3. The intention to publish date was changed from 31/08/2021 to 31/08/2022.
4. The plain English summary was updated to reflect these changes.
28/05/2020: Due to current public health guidance, recruitment for this study has been paused.
07/04/2020: Internal review.
26/09/2019: Trial's existence confirmed by ethics committee.
