A study to prevent ovarian cancer by removing the fallopian tubes and then the ovaries (PROTECTOR)
Cancer type:
Status:
Phase:
This study is looking at preventing ovarian cancer in women at increased risk by removing the fallopian tubes first and then the ovaries at a later date.
You are at an increased risk of developing ovarian cancer if you:
- have a gene change (mutation) such as PALB2, BRCA1, BRCA2, RAD51C, RAD51D or BRIP1
or
- have a strong family history of cancer
More about this trial
The 
for women who have an increased risk of ovarian cancer is surgery to remove their fallopian tubes and ovaries at the same time. Doctors call this a risk reducing salpingo oophorectomy (RRSO).
A large number of women usually have this surgery before the . By removing the ovaries early they go through early onset menopause. And this can have some health concerns including:
- hot flushes and sweats
- mood changes
- thinning of the bones (osteoporosis)
- higher risk of heart disease
- loss, or reduction of sexual function and desire (libido)
- memory loss
Some women delay having or don’t have RRSO surgery to avoid early menopause and its potential problems.
Current research suggests that many ovarian cancers start in the fallopian tubes.
Researchers think that a 2 stage operation might be better than RRSO. The first stage is to remove the fallopian tubes. The second stage is to remove the ovaries with another operation later. This might give women another choice apart from RRSO to reduce their risk of ovarian cancer. This is particularly helpful for women who delay or prefer not to have RRSO especially before the menopause.
But it isn’t known by how far the risk of ovarian cancer might be reduced by removing the fallopian tubes first.
Doctors call this new 2 stage surgery a risk reducing early salpingectomy and delayed oophorectomy (RRESDO).
In this study you can choose to have either:
- RRSO surgery (one operation) or
- RRESDO surgery (two operations) or
- no surgery
The aims of the study are to find out:
- how RRESDO surgery affects sexual function
- how this surgery affects
quality of life - how satisfied women are with their choice
- the outcomes of having RRSO and RRESDO surgery
- how many early cancers are identified after RRESDO or RRSO when the removed tissue is looked in the laboratory
- what are the costs of RRESDO surgery
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if you are a woman at risk of developing ovarian because:
- you have certain
gene changes (mutations ) such as PALB2, BRCA1, BRCA2, RAD51C, RAD51D or BRIP1
or
- you have a strong family history of breast cancer and ovarian cancer
or
- you have a strong family history of ovarian cancer
And all of the following apply. You:
- are 30 years of age or older
- have not gone through the menopause (you are premenopausal)
In order to join one of the surgical arms of the study (RRSO or RRESDO) you must have completed having your family. You can join the ‘no surgery’ arm if you have not yet completed having your family.
Who can’t take part
You cannot join this study if any of these apply. You:
- have had both your fallopian tubes removed (bilateral salpingectomy) or both your ovaries removed (bilateral oophorectomy)
- have gone through the menopause (post menopausal)
- have had, or your doctor thinks you might have fallopian tube cancer or ovarian cancer
- have had a cancer in the
peritoneum - have had cancer treatment less than 6 months ago
- are pregnant
Trial design
The team need 1,250 women to join the study. There are 3 groups (cohorts) in this study. You choose which group you go into. The groups are:
- Risk Reducing Early Salpingectomy and Delayed Oophorectomy (RRESDO)
- Risk Reducing Salpingo Oophorectomy (RRSO)
- Control or No surgery
RRESDO
This is the new 2 stage operation to prevent ovarian cancer. In the first stage you have your fallopian tubes removed. In the second stage you have your ovaries removed.
You choose when to have your ovaries removed at a later date after the first operation. You might choose to have your ovaries removed before you go through the menopause naturally. If not, then you should have this done after you have gone through the menopause.
Should you choose to have your ovaries removed before going through the menopause your doctor will talk to you about having hormone replacement therapy ().
Before your RRESDO surgery.
After the first stage (Early Salpingectomy) of your RRESDO surgery.
After the second stage (Delayed Oophorectomy) of your RRESDO surgery.
RRSO
This is the standard treatment for women at risk of ovarian cancer. You have both your fallopian tubes and ovaries removed at the same time.
Before your RRSO surgery.
After your RRSO surgery.
Control or No Surgery
You can choose not to have your fallopian tubes or ovaries removed at this time. This might be because you:
- want children
- would like to delay till you’ve gone through the menopause or
- aren’t ready to have the operation
You can choose at any time to have either RRESDO or RRSO surgery during the study. Let your study doctor know and they will tell you about the operations.
Surgery
For all the operations you have a .
Where possible the surgeons do this as . This means you have small cuts instead of one large cut in your tummy (abdomen). You stay in hospital for a day. Recovery after the operation takes about 1 to 2 weeks. After this you should be able to do you normal daily activities.
For a number of reasons a small number of women can’t have keyhole surgery. Instead you have surgery using a large cut in your tummy (abdomen). You need to stay in hospital for 5 days. Recovery after the operation takes 6 weeks. After this you should be able to do you normal daily activities.
During the operation the surgeon takes tissue (fallopian tubes and ovaries) and some fluid (washings) from your tummy. The surgeon sends these to the laboratory so that a specialist called a can look at the cells under a microscope. They look for any signs that the cells in the tissue and fluid are abnormal, pre cancer or cancer.
If they find pre cancer or cancer cells your doctor will refer you to a specialist in women’s cancer (gynaecological oncologist).
For women who haven’t gone through the menopause your doctor will talk to you about having hormone replacement therapy (HRT) after your operation.
Interviews
The team will interview a small number of women. They will ask about:
- factors influencing your decision
- how acceptable the treatments are
- your willingness to have the 2 stage operation (RRESDO)
The interview takes about an hour and will be recorded.
The team interview women in the surgery groups again a year after their operation. This is to find out:
- how satisfied they were with the process
- general health and wellbeing
This interview will also be recorded.
You don’t have to answer any questions if you don’t want to. You can also stop the interview at any time.
You don’t have to agree to do the interview. You still can take part in the study.
Quality of life
You fill in a few questionnaires:
- when you join the study
- at regular times during the study
The questions ask about:
- your quality of life
- your family history
- medical history
- cancer worry
- mental and emotional (psychological) wellbeing
- how satisfied you are with your decision
Hospital visits
You see the doctor to have some tests before taking part. These tests include:
- blood tests
- ultrasound (only if you are having surgery)
If you are having RRSO or RRESO surgery, you see the doctor after having your operation at:
- 1 month
- 3 months and then
- every year for 3 years
Women having RRESDO have another ultrasound and some blood tests before your second operation.
After you have the second operation (delayed oophorectomy) you see the doctor at:
- 1 month
- 3 months
- 1 year
Control (no operation)
You see the doctor:
- every year for 3 years
- when you go through the menopause and then
- a year later
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
All surgery can have risks and complications. These can include:
• wound infections and urine infections
• blood clot in the leg (DVT) or in the lung (pulmonary embolism)
• chesty cough (chest infection)
• damage to the bowel, bladder or tubes that drain the urine (ureters)
Having 2 separate operations can also increase your risk of getting complications.
After having surgery to prevent ovarian cancer there is a small risk you might still develop cancer of the peritoneum called peritoneal cancer.
Early menopause
There are some possible effects when you have an early menopause. These include:
- hot flushes
- sweats
- mood changes
- thinning of the bones (osteoporosis)
- memory problems
- an increased risk of heart disease and stroke
- a decrease in sexual desire (libido)
- loss of sexual function or reduced function
Your doctor or a member of the study team will talk to you about the possible risks of surgery and early menopause before you agree to join the study.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Ranjit Manchanda
Supported by
Queen Mary University of London
Barts and the London Charity
Rosetrees Trust
The Eve Appeal
Ovarian Cancer Action
Ovacome
BRCA Umbrella
Target Ovarian Cancer
NCRI Gynaecological Cancer Clinical Studies Group
GO Girls
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
