Status
Ongoing
Title
Use of hormone replacement therapy and survival from cancer
What is the aim of the study and why is it important?
The aim of the study is to determine the association between HRT use after cancer diagnosis and cancer-specific mortality in patients with common female cancers, excluding breast cancer. Hormone replacement therapy (HRT) is widely used. HRT is proven to reduce menopausal related vasomotor symptoms (hot flashes, flushing, and night sweats) and urogenital atrophy. HRT preserves bone mass and is approved by the Food and Drug Administration to prevent postmenopausal osteoporosis. It has also been shown to reduce joint pain, mood swings, sleep disturbances and improve quality of life and, consequently, it has been acknowledged that a reluctance to teat menopausal symptoms can cause unnecessary suffering. However, the role of oestrogen in cancer development and progression is complex. Recent studies have suggested HRT could be protective in women with melanoma, colorectal and liver cancer. In contrast, there have been concerns that HRT could accelerate cancer progression in women with lung, bladder, gastric, and brain cancer. Consequently, some researchers have recommended against using HRT in women with these cancers. However, epidemiological studies have not investigated the survival of women using HRT after diagnosis of most cancers and therefore the safety of HRT use in cancer patients remains unclear.
How is the research being done?
In QResearch, cohorts of women newly diagnosed with common cancers from 1998 to 2016 will be identified from English cancer registries. Women with breast cancer will be excluded. HRT use will be determined from GP records. The primary outcome will be time to death from cancer from national mortality records. Time to death from cancer will be determined in cancer patients who used HRT and compared with cancer patients who did not use HRT. Similar analyses will be conducted in Wales using SAIL databank and Scotland based upon the national Prescribing Information System. The findings will then be pooled across the 3 countries.
Chief Investigator
Dr Chris Cardwell (Belfast) Julia Hippisley-Cox (Oxford)
Lead Applicant Organisation Name
Sponsor
Oxford
Location of research
Oxford
Date on which research approved
05-Mar-2020
Project reference ID
OX24
Generic ethics approval reference
18/EM/0400
Are all data accessed are in anonymised form?
Yes
Brief summary of the dataset to be released (including any sensitive data)
Women newly diagnosed with common cancers from 1998 to 2016 will be identified from English cancer registries linked to QResearch. The primary outcome of death from cancer will be determined from ONS mortality records. Information of relevance to cancer survival will be determined including: age, year of diagnosis, cancer specific data (including stage, treatments and grade from cancer registry records), comorbidities (including Charlson comorbidity conditions, prior hysterectomy/oophorectomy from GP records), medication use (including HRT, aspirin, statins and other medications from GP records), deprivation, smoking and BMI (from GP records).
Implications and Impact
The goal of our study is to provide female cancer patients with information to allow them to make an informed decision on whether to use HRT or switch to alternatives (such as selective serotonin reuptake inhibitors and clonidine). Our study will also provide mechanistic insights into the role of oestrogen in cancer progression.
Funding Source
Cancer Research UK
Public Benefit Statement
Research Team
Dr Chris Cardwell, Professor Julia Hippisley-Cox, Dr Bland Hicks, Dr Una McMenamin, Professor carol Coupland
Publications
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Hormone replacement therapy in women with cancer and risk of cancer-specific mortality and cardiovascular disease: a protocol for a cohort study from Scotland and Wales
Authors: Úna McMenamin, Blánaid Hicks, Carmel Hughes, Peter Murchie, Julia Hippisley-Cox, Tom Ranger, Carol Coupland, Chris Cardwell
Ref:
https://pubmed.ncbi.nlm.nih.gov/33761919/ -
Hormone replacement therapy and cancer survival: a longitudinal cohort study: protocol paper
Authors: Tom Alan Ranger, Judith Burchardt, Ashley Kieran Clift, Winnie Xue Mei, Carol Coupland, Pui San Tan, Sharon Dixon, Christopher Robert Cardwell, Julia Hippisley-Cox
Ref:
https://pubmed.ncbi.nlm.nih.gov/34341043/
Press Releases
Access Type
Trusted Research Environment (TRE)