Breast activity and healthy eating after diagnosis 3
| ISRCTN | ISRCTN12841416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12841416 |
| Secondary identifying numbers | 18070 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 27/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Many breast cancer patients are above an ideal weight, with high body fat and low muscle stores. Many patients gain fat and lose muscle during chemotherapy, and too much fat and low muscle stores can make chemotherapy less effective and increase its side effects. The aim of this study is to test the potential beneficial effects of a calorie-restricted diet and resistance exercise on breast cancer patients scheduled to receive chemotherapy. Resistance exercise is also known as strength training, and is performed to increase muscle and bone strength.
Who can participate?
Patients aged over 18 with breast cancer who are scheduled to receive chemotherapy or up to Day 15 or first cycle.
What does the study involve?
Participants are randomly allocated to one of two groups. One group follows a diet and exercise programme which includes a calorie-restricted diet and resistance training 3 times per week. The other group do resistance (strength) training 3 times per week. Both groups are asked to follow these programmes during their current course of chemotherapy, and are phoned by the study researchers every 3 weeks during the study to check their progress and provide further advice and support. Research nurses in the treatment centre review patients at each chemotherapy treatment and assess weight and any side effects of the chemotherapy. The following outcomes are assessed: time to disease progression, chemotherapy toxicity, quality of life, fatigue, change in weight, waist circumference, fat and muscle mass.
What are the possible benefits and risks of participating?
Healthy eating and exercise advice is not a routine part of standard breast cancer treatment. All participants will be encouraged to eat healthily and lead a healthy active lifestyle during their chemotherapy treatment. Following this advice may prevent weight gain or promote slow weight loss, which may improve your treatment outcomes and wellbeing. The plans may also reduce side effects of chemotherapy. The recommended diet and exercise programmes have been designed by expert cancer dietitians and exercise specialists and are known to be safe for breast cancer patients. The test diet will meet all nutritional needs. All participants will be offered individualised advice on diet and exercise at the end of the study. Participants will be contributing to scientific knowledge about the benefits of diet and exercise after breast cancer diagnosis. This will help us to develop a well-researched programme which may benefit future breast cancer patients.
Where is the study run from?
1. Manchester University NHS Foundation Trust
2. The Christie NHS Foundation Trust
3. Leighton Hospital
4. The Royal Liverpool University Hospital
5. Clatterbridge Hospital
6. Macclesfield District General Hospital
7. North Manchester General Hospital
8. Royal Oldham Hospital
9. Royal Stoke University Hospital
10. Tameside General Hospital
11. Royal Albert Edward Infirmary
12. Royal Devon and Exeter Hospital
When is the study starting and how long is it expected to run for?
February 2015 to April 2023
Who is funding the study?
Anticancer Fund (Belgium)
Who is the main contact?
Michelle Harvie, michelle.harvie@manchester.ac.uk
Contact information
Scientific
Research Dietitian
Prevent Breast Cancer Research Unit
Manchester University Hospital Foundation NHS Trust
Wythenshawe
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 4410 |
|---|---|
| michelle.harvie@manchester.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised phase II trial of intermittent energy restriction and resistance exercise in women receiving chemotherapy for advanced breast cancer |
| Study acronym | B-AHEAD3 |
| Study hypothesis | Current Hypothesis as of 01/03/2018: This randomised trial will test the potential beneficial effects of a calorie restricted diet and resistance exercise compared to a resistance exercise programme on disease progression amongst 134 metastatic breast cancer patients scheduled to receive chemotherapy Previous Hypothesis: This randomised trial will test the potential beneficial effects of a calorie restricted diet and resistance exercise compared to a resistance exercise programme on disease progression amongst 134 metastatic breast cancer patients scheduled to receive paclitaxel or capecitabine chemotherapy. This is a randomised phase II screening trial. If the results from this diet and exercise weight loss intervention are positive we will look to perform a national phase III study. |
| Ethics approval(s) | North West - Greater Manchester West Research Ethics Committee, 10/12/2014, ref: 14/NW/1396 |
| Condition | Breast cancer |
| Intervention | Group 1: Diet and exercise. This group have an individual session with the trial dietitian and are asked to follow our 5:2 calorie restricted diet tailored to their needs and preferences. This group will also have an individual session with the trial physiotherapist or exercise specialist to teach them the resistance exercise which they will be asked to do three times a week. Resistance exercise is also known as strength training, and it is performed to increase the strength and mass of muscles, bone strength. Group 2: Exercise. This group will also have an individual session with the trial physiotherapist or exercise specialist to teach them the resistance exercises which they will be asked to do three times a week. They will be given general written dietary advice on healthy eating, coping with the side effects of chemotherapy and food hygiene. Both groups will be phoned by BAHEAD by 3 researchers every 3 weeks during the study to check their progress and provide further advice and support. Research nurses in the treatment centre will review patients at each chemotherapy treatment and assess weight and any side effects of the chemotherapy. We will examine the difference between the two groups on: Time to disease progression, chemotherapy toxicity, quality of life, fatigue, change in weight, waist circumference, fat and muscle mass which we can assess from their routine treatment CT scan. |
| Intervention type | Mixed |
| Primary outcome measure | Progression-free survival (PFS) |
| Secondary outcome measures | Time to Treatment Failure (TTF) i.e. the time from randomisation to disease progression, death |
| Overall study start date | 01/02/2015 |
| Overall study end date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 134; UK Sample Size: 134 |
| Total final enrolment | 68 |
| Participant inclusion criteria | As of 17/05/2016: 1.Women with histologically confirmed breast cancer 2. Patients with ABC, i.e. locally advanced disease that is not amenable to curative surgical resection or with metastatic disease 3. HER2 positive or negative 4. ER and/or PR positive or negative 5. If ER positive there is no restriction on the number of lines of previous endocrine therapy for ABC 6. Performance status 0 or 1 7. Predicted life expectancy ≥ 3 months 8. BMI ≥24 kg/m2 9. Expressing a wish to lose weight 10. Not already entered or planned to enter a trial of an investigational medicinal product (IMP) for this line of therapy 11. Age >18 (can be pre or post menopausal) 12. Measurable or non-measurable disease by RECIST v1.1 13. Patients with brain or leptomeningeal metastases are eligible as long as all sites have been treated with radiotherapy (+/- surgery) with evidence of disease control at least 8 weeks after the last dose 14. Women in whom further endocrine therapy is planned after chemotherapy are eligible. The treating clinician must state what endocrine therapy is planned before chemotherapy is initiated 15. Women with thyroid dysfunction are eligible provided they are euthyroid and on a stable dose of thyroxine for the last 6 months Previous: 1. Women with histologically confirmed breast cancer 2. Patients with advanced breast cancer (ABC) i.e. locally advanced disease that is not amenable to curative surgical resection or with metastatic disease 3. Her2 negative by IHC defined as 0/1+ or 2+ with FISH/DDISH/CISH ratio <2.0 4. ER and or PR positive or negative 5 If ER positive there is no restriction on the number of lines of previous endocrine therapy for ABC 6. No more than one line of chemotherapy for locally advanced or metastatic breast cancer. A line of chemotherapy is defined as a treatment given with palliative intent and of at least 4 weeks duration. If chemotherapy was given for less than 4 weeks and stopped due to excess toxicity, with NO evidence of progression either clinically, biochemically or radiologically, then this will not be counted as a line of therapy. If an attempt to downstage a locally advanced tumour with chemotherapy was made in the absence of metastatic breast cancer (MBC), and the tumour operated upon, then this does not count as a line of therapy for ABC. In contrast, if the tumour remained inoperable then this treatment should be included as a line of therapy for ABC. 7. In the opinion of the treating clinician suitable for treatment with ‘full dose’ weekly paclitaxel (8090mg/m2 weekly with no rest weeks) or capecitabine 10001250mg/m2 twice daily for 14 days followed by a rest week. 8. Performance status 0 or 1 9. BMI>25 kg / m 2 and body fat >30% (determined from impedence/ or CT scan) or waist circumference > 80cm 10. Expressing a wish to lose weight 11. Not already entered or planned to enter a trial of an investigational medicinal product (IMP) for this line of therapy 12. Age >18 (can be pre or post menopausal) 13. Measurable or nonmeasurable disease by RECIST v1.1 14. Patients with brain or leptomeningeal metastases are eligible as long as all sites have been treated with radiotherapy (+/surgery) with evidence of disease control at least 8 weeks after the last dose 15. Women in whom further endocrine therapy is planned after chemotherapy are eligible. The treating clinician must state what endocrine therapy is planned before chemotherapy is initiated. 16. Women with thyroid dysfunction are eligible provided they are euthyroid and on a stable dose of thyroxine for the last 6 months |
| Participant exclusion criteria | As of 17/05/2016: 1. Physical or psychiatric conditions which may reduce compliance to and the safety of diet or resistance exercise, e.g. 1.1. Serious digestive and/or absorptive problems, including active inflammatory bowel disease. 1.2. Psychiatric disorders or conditions, e.g. history of eating disorders, untreated major depression, psychosis, substance abuse, severe personality disorder. 1.3. Bone metastases at risk of pathological fracture or that would limit resistance exercise through pain in all three areas of the body that are covered by the resistance exercises (upper limbs, trunk and lower limbs). Metastases may be ok if other areas of the body can safely be exercised. 2. Medications affecting adiposity or muscle mass and function and energy intake e.g. continuous daily steroids for longer than 4 weeks (short term steroids with chemotherapy are acceptable) 3. Diabetics on insulin or sulphonylureas (glibenclamide, gliclazide, glimepiride, glipizide, tolbutamide) as they could experience hypoglycaemia on restricted days of the intermittent diet (diabetics treated with diet alone or with any other medication including metformin are eligible) 4. Greater than Day 15 of this course of chemotherapy. 5. Visceral metastases that, in the opinion of the treating clinician, would result in death within 3 months if no response was achieved with this line of chemotherapy 6. Symptomatic or uncontrolled brain or leptomeningeal metastases Previous: 1. Physical or psychiatric conditions which may reduce compliance to and the safety of diet or resistance exercise eg. serious digestive and/or absorptive problems, including active inflammatory bowel disease. 2. Psychiatric disorders or conditions, e.g. history of eating disorders, untreated major depression, psychosis, substance abuse, severe personality disorder. 3. Bone metastases at risk of pathological fracture or that would limit resistance exercise through pain. 4. Medications affecting adiposity or muscle mass and function and energy intake e.g. continuous daily steroids for longer than 4 weeks (short term steroids with chemotherapy are acceptable) 5. Diabetics on insulin or sulphonylureas (glibenclamide, gliclazide, glimepiride, glipizide, tolbutamide) as they could experience hypoglycaemia on restricted days of the intermittent diet (diabetics treated with diet alone or with any other medication including metformin are eligible) 6. Already commenced this course of first or second line chemotherapy 7. Visceral metastases that, in the opinion of the treating clinician, would result in death within 3 months if no response were achieved with this line of chemotherapy 8. Patients relapsing within 12 months of adjuvant/neoadjuvant chemotherapy 9. Symptomatic or uncontrolled brain or Leptomeningeal metastases |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 31/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Manchester
M20 4BX
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Liverpool
L7 8XP
United Kingdom
Bebington
Birkenhead
Wirral
CH63 4JY
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
Oldham
OL1 2JH
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Ashton-under-Lyne
OL6 9RW
United Kingdom
Wigan
WN1 2NN
United Kingdom
Exeter
EX2 5DW
United Kingdom
Sponsor information
Hospital/treatment centre
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned submission to a high-impact peer-reviewed journal |
| IPD sharing plan | Current IPD sharing statement as of 06/04/2023: The datasets generated during and/or analysed during the current study are/will be available upon request from Michelle Harvie (michelle.harvie@manchester.ac.uk) within reasonable request if covered by study approvals and patient consents and approved by Trial Steering Committee and Data Management Committee. Toxicity and body composition data available after study publication for 5 years. Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Mary Harvie (michelle.harvie@manchester.ac.uk) within reasonable request if covered by study approvals and patient consents and approved by Trial Steering Committee and Data Management Committee. Toxicity and body composition data available after study publication for 5 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 7.0 | 02/10/2018 | 04/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
27/09/2023: Internal review.
13/09/2023: The following changes were made:
1. The intention to publish date was changed from 30/09/2023 to 30/12/2023.
2. The scientific contact was changed and the IPD and plain English summary contacts were updated accordingly.
06/04/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 07/04/2021 to 30/04/2023.
2. The intention to publish date was changed from 31/03/2022 to 30/09/2023.
3. The IPD sharing statement was updated.
17/10/2022: The intention to publish date was changed from 31/10/2022 to 30/04/2023.
04/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
08/03/2022: The following changes were made to the trial record:
1. The total final enrolment was changed from 65 to 68.
2. The intention to publish date was changed from 31/03/2022 to 31/10/2022.
21/09/2021: Removed incorrect ClinicalTrials.gov number.
20/09/2021: The following changes have been made:
1. The recruitment end date was changed from 07/04/2021 to 31/03/2021.
2. The overall trial end date was changed from 31/03/2021 to 07/04/2021.
3. The intention to publish date was changed from 31/10/2023 to 31/03/2022.
4. Total final enrolment added.
09/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2021 to 07/04/2020. Recruitment was not restarted after the pause.
2. The overall trial end date has been changed from 31/10/2022 to 31/03/2021.
09/07/2020: The trial contact details have been made publicly visible.
07/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/03/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/02/2020 to 31/10/2021.
2. The overall end date was changed from 01/02/2021 to 31/10/2022.
3. The intention to publish date was changed from 31/12/2021 to 31/10/2023.
4. The plain English summary was updated to reflect these changes.
23/07/2019: ClinicalTrials.gov number added.
03/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast" to "Breast cancer" following a request from the NIHR.
14/02/2019: IPD sharing statement added.
13/02/2019: The following changes were made to the trial record:
1. Contact details updated.
2. Sponsor changed from "University Hospital of South Manchester NHS Foundation Trust (UK)" to "Manchester University NHS Foundation Trust"
3. Trial participating centres added.
14/03/2018: The following changes were made:
1. Recruitment start date was updated from 01/02/2015 to 01/05/2018
2. Recruitment end date was updated from 01/04/2018 to 01/02/2020
3. Overall trial end date was updated from 01/04/2020 to 01/02/2021
4. Trial participating centre name was amended from University Hospital of south Manchester,
Genesis Prevention Centre to The Nightingale Centre, Manchester University NHS Foundation Trust
01/03/2018: The hypothesis has been updated.
04/07/2017: The location of the funding body was incorrectly identified as the UK. It has now been updated to Belgium in the Plain English summary and in the funder tab.
16/06/2016: Plain English summary added.
08/03/2017: The overall trial end date has been updated from 01/04/2018 to 01/04/2020 and the recruitment end date has been updated from 01/04/2017 to 01/04/2018
08/06/2016: The overall trial end date has been updated from 01/04/2017 to 01/04/2018 and the recruitment end date has been updated from 01/04/2016 to 01/04/2017
17/05/2016: The overall trial end date was changed from 01/04/2016 to 01/04/2017.
