To evaluate how effective a guided self- help cognitive behavioural therapy (CBT) intervention is in reducing the impact of hot flushes and night sweats (compared to treatment as usual) at 6 months post randomisation in men taking hormone therapy for prostate cancer

Not Applicable

• Conditions: Sweating caused by prostate cancer androgen deprivation therapy; Cancer

• Registration Number: ISRCTN58720120
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37430353/ (added 11/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-13
• Last Update Posted: 25 July 2023
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. A diagnosis of prostate cancer
2. Localised or advanced disease stage. Patients may have had potentially curative treatments including, but not limited to, radiotherapy, brachytherapy or surgery.
3. Currently receiving ADT, and anticipated to require a minimum of 6 months further continuous treatment at the point of registration into the trial. Treatment may have been planned for either a fixed duration (for example, but not limited to, 2 years after radiotherapy) or permanent. Treatment
may be with either adjuvant (following potentially curative treatment) or palliative intent. LHRH analogues, LHRH antagonists and surgical castration are all acceptable forms of androgen deprivation. Androgen receptor antagonists, including but not limited to, bicalutamide, enzalutamide, apalutamide or darolutamide, or abiraterone, may be given in combination with androgen deprivation according to local practice.
4. Presence of problematic HFNS symptoms defined as a HFNS Rating Scale score of two or more.
5. Ability to read and understand English without assistance
6. 16 years or older
7. Ability to attend virtual (or face-to-face) group workshops through video conferencing software. If this is not feasible, participants must be able to participate in one-to-one workshops by telephone

Exclusion Criteria

1. Currently with uncontrolled biochemical, radiological or clinical disease progression or relapse if this would be anticipated to interfere with trial participation as determined by the local principal investigator or co-investigator
2. Currently receiving chemotherapy. Prior chemotherapy must have been completed with a minimum of 4 weeks elapsed between the date of the final dose and confirmation of eligibility. Concomitant use of bone health agents, including zoledronate and denosumab is allowed
3. Currently receiving radical multi-fraction external beam radiotherapy or brachytherapy These must have been completed with a minimum of 4 weeks elapsed between the date of the final fraction/treatment and confirmation of eligibility. Single fraction radiotherapy to sites of painful bony
metastatic disease or ‘STAMPEDE style’ palliative prostate radiotherapy is allowed
4. Intention to receive ADT on an intermittent schedule
5. Use of experimental drugs within other interventional clinical trials. Co-recruitment to observational studies, or studies of surgery or focal ablation techniques where the interventional component is complete, is acceptable
6. Currently receiving androgen deprivation as a neoadjuvant treatment
7. Medical or psychiatric conditions or other factors that, in the view of the local PI, are likely to impact on the ability of the patient to participate in the trial procedures and interventions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hot flush and night sweat symptoms measured using the HFNS Rating Scale at baseline and 6 months