MenopausePhase 2MACSNCT04766229
The Menopause After Cancer Study
A Phase 2 study testing Citalopram +/- Gabapentin + Sleepio + support person in people with Menopause and Cancer, run by University College Dublin at 2 sites in Ireland.
Trial summary
This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Citalopram +/- Gabapentin + Sleepio + support person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesIreland
- Study dates
- 21 Jun 2021to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females over 18 years of age at the time of recruitment and onboarding.
- Vasomotor symptoms of menopause
- Previous or current cancer diagnosis
- Conventional menopausal hormone therapy contraindicated for any reason
- Can speak and read English proficiently
- Competent using the internet and has access to smartphone or similar device
Who cannot join
- ECOG performance status >3
- Use of study medications to manage menopausal symptoms in the preceding 6 months
- Use of CBT for insomnia in the preceding 6 months
- Any contraindication to study medications
- No internet access or competency issue with internet use
- Unable to complete questionnaires or give informed consent
- Current major mental illness
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Mater Misericordiae University Hospital
Dublin
St. Vincent's University Hospital
Dublin
About this study
Official title: A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.
Read the detailed description
Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. They will be given access to an evidence based platform for digital CBT for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.
- Being tested
- Citalopram +/- Gabapentin + Sleepio + support person
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram +/- Gabapentin + Sleepio + support personCombination product
All participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants in single arm study Receives: Combination Product: Citalopram +/- Gabapentin + Sleepio + support person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument
Global quality of life will be assessed using the EORTC QLQ C30 questionnaire. This is a 30 item questionnaire which has been extensively validated internationally and is specific to patients treated for cancer. Minimum global quality of life score is 0 with a maximum of 100 with a higher score representing a better quality of life.
Measured: 6 months
Secondary outcomes (2)
Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale
This will be measured by the Hot Flush Rating Scale which measures both frequency and impact of vasomotor symptoms. For this scale the minimum score is 1 and maximum score is 10 with higher scores indicating a greater degree of bother/interference.
Measured: 6 months
Sleep dysfunction as measured by the Sleep Condition Indicator
This will be measured using the Sleep Condition Indicator tool. Minimum score is 0 with maximum score of 32 with higher scores indicating better sleep.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start21 Jun 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Cancer Society, Big Health Inc., myPatientSpace
- Responsible party
- Principal investigator, Donal Brennan, University College Dublin
- Investigators
- Donal Brennan, PhD, Principal investigator, UCD Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766229
- Sponsor's protocol ID
- RS21-002
- Acronym
- MACS
- Status last verified
- Jan 2023
- First submitted
- 17 Feb 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share IPD with other researchers
Publications
Donohoe F, O'Meara Y, Roberts A, Comerford L, Kelly CM, Walshe JM, Peate M, Hickey M, Brennan DJ. The menopause after cancer study (MACS) - A multimodal technology assisted intervention for the management of menopausal symptoms after cancer - Trial protocol of a phase II study. Contemp Clin Trials Commun. 2021 Nov 11;24:100865. doi: 10.1016/j.conctc.2021.100865. eCollection 2021 Dec.
PubMed 34869938
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
- ClinicalTrials.gov ID
- NCT04766229
- Acronym / sponsor ID
- MACS / RS21-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Irish Cancer Society, Big Health Inc., myPatientSpace
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.
Detailed description
Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. They will be given access to an evidence based platform for digital CBT for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Combination Product: Citalopram +/- Gabapentin + Sleepio + support personAll participants in single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females over 18 years of age at the time of recruitment and onboarding.
- Vasomotor symptoms of menopause
- Previous or current cancer diagnosis
- Conventional menopausal hormone therapy contraindicated for any reason
- Can speak and read English proficiently
Key exclusion criteria (7 listed)
- ECOG performance status >3
- Use of study medications to manage menopausal symptoms in the preceding 6 months
- Use of CBT for insomnia in the preceding 6 months
- Any contraindication to study medications
- No internet access or competency issue with internet use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram +/- Gabapentin + Sleepio + support personAll participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person | Combination product | Single Arm |
Primary outcome
Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument
Time frame: 6 months
Global quality of life will be assessed using the EORTC QLQ C30 questionnaire. This is a 30 item questionnaire which has been extensively validated internationally and is specific to patients treated for cancer. Minimum global quality of life score is 0 with a maximum of 100 with a higher score representing a better quality of life.
2 secondary outcomes
Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale
Time frame: 6 months
Sleep dysfunction as measured by the Sleep Condition Indicator
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 34869938Donohoe F, O'Meara Y, Roberts A, Comerford L, Kelly CM, Walshe JM, Peate M, Hickey M, Brennan DJ. The menopause after cancer study (MACS) - A multimodal technology assisted intervention for the management of menopausal symptoms after cancer - Trial protocol of a phase II study. Contemp Clin Trials Commun. 2021 Nov 11;24:100865. doi: 10.1016/j.conctc.2021.100865. eCollection 2021 Dec.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donal Brennan, PhD principal investigator
UCD Dublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram +/- Gabapentin + Sleepio + support person in people with Menopause and Cancer, run by University College Dublin at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.