Breast activity and healthy eating after diagnosis - 2 During chemotherapy for early breast cancer

ISRCTN	ISRCTN04156504
DOI	https://doi.org/10.1186/ISRCTN04156504
Protocol serial number	13255
Sponsor	University Hospital of South Manchester (UK)
Funder	Breast Cancer Research Trust (UK)

Submission date: 19/11/2012
Registration date: 19/11/2012
Last edited: 28/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-healthy-eating-exercise-women-having-chemotherapy-breast-cancer-b-ahead-2

Contact information

Ms Mary Pegington
Scientific

Wythenshawe Hospital
Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	mary.pegington@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized interventional and observational trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Breast activity and healthy eating after diagnosis - 2 During chemotherapy for early breast cancer
Study acronym	B-AHEAD 2
Study objectives	Excess weight at the time of breast cancer diagnosis and weight gain during adjuvant chemotherapy increases the risk of breast cancer recurrence and death. We and others have demonstrated that continuous energy restriction (CER) and exercise is only partially effective at limiting the 2.5-3kg weight gain which occurs during chemotherapy, and for promoting weight loss for overweight women. Our other studies in non cancer patients have shown intermittent energy restriction (IER) is equivalent or superior to continuous restriction for weight control, and our pilot studies indicate that IER could be useful amongst chemotherapy patients because the days after chemotherapy administration can be avoided. The purpose of this study is to formally assess the feasibility and effectiveness of IER to prevent chemotherapy induced weight gain and promote weight loss for overweight women compared with continuous energy restriction in a randomised trial (n=170). This study will re test whether continuous energy restriction can be effective, and whether the novel IER is better. The trial aims to identify a much needed regimen for weight control and toxicity reduction for breast cancer patients receiving chemotherapy. If either of our test regimes are succesful, this would then be tested in a larger phase III trial to evaluate its effects on relapse free and overall survival. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13255
Ethics approval(s)	NRES Committee North West - Greater Manchester West, 04 April 2012, ref: 12/NW/0230
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention	Comparison group (n = 85) Continuous energy restricted Mediterranean diet plus an exercise intervention (2.5 hours/ moderate activity week) Intervention group (n = 85) 2 consecutive days / week of energy restriction with an intermittent low energy diet (<50g carbohydrate / day and ad lib protein diet [self limits to approximately 800-1000 kcal/day]), and a Mediterranean diet for 5 days/week, plus an exercise intervention (2.5 hours/ moderate activity week).
Intervention type	Other
Primary outcome measure(s)	Weight, body fat (DXA, impedence), waist and hips measured twice at baseline and post chemotherapy appointments
Key secondary outcome measure(s)	1. Blood markers of chemotherapy associated toxicity measured twice at the first and final chemotherapy cycles 2. Examining the effects of the restricted and normal intake phases measured once at the final chemotherapy cycles 2. Quality of life and fatigue (functional assessment of cancer therapy; FACT-B, FACT-ES and FACT-F; measured twice at baseline and post chemotherapy appointments; 3. Serum markers of breast cancer risk prognosis measured twice at baseline and post chemotherapy appointments 4. Serum markers of cardiovascular disease measured twice at baseline and post chemotherapy appointments 5. Fitness measured twice at baseline and post chemotherapy appointments 6. Blood markers of oxidative stress measured twice at baseline and post chemotherapy appointments 7. Motivational, stage of behaviour change, health beliefs, and self-efficacy scales measured twice at baseline and post chemotherapy appointments 8. Dietary intake (7 day food diary), accelerometer and physical activity questionnaire measured at three times at baseline, post chemotherapy appointments, and half way through chemotherapy 9. Differences in self reported chemotherapy toxicity measured at each chemotherapy cycle
Completion date	20/11/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	170
Total final enrolment	172
Key inclusion criteria	1. Scheduled to have standard adjuvant or neoadjuvant chemotherapy 2. Breast cancer stage I to III 3. Any age >18 years: weight affects prognosis amongst preand post menopausal women 4. BMI>19 Kg / m2 (Using IER and exercise we aim to avoid weight gain in all patients; this may lead to some weight loss in normal weight individuals). 5. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries. 6. Resident within Greater Manchester or Cheshire area only in order to maximise uptake and retention to interventions and study. 7. Written informed consent
Key exclusion criteria	1. Metastatic disease 2. Previouly had chemotherapy for breast or any cancer within the last 2 years. 3. Physical/or psychiatric conditions which may impair compliance to the diet or physical activity interventions assessed from medical history by recruitment nurse/ clinician i.e. Serious digestive and/or absorptive problems, including inflammatory bowel disease. Cardiovascular, respiratory (determined from recent preoperative ECG, chest Xray, and verified from baseline fitness assessment by the trial exercise specialist (DM) Musculoskeletal disease or joint problems. Psychiatric disorders or conditions, e.g. untreated major depression, psychosis, substance abuse, severe personality disorder. 4. Medications affecting weight e.g. metformin or continuous daily steroids (23 days with chemotherapy allowed) 5. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the diabetiologist. Non-insulin requiring diabetics are eligible for the study. 6. Already commenced chemotherapy. 7. Scheduled to have weekly paclitaxel
Date of first enrolment	26/11/2012
Date of final enrolment	26/03/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Wythenshawe Hospital

Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/12/2021	17/12/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Protocol file	version 9	04/08/2017	28/02/2023	No	No

Additional files

ISRCTN04156504_PROTOCOL_V9_04Aug17_.pdf: Protocol file

Editorial Notes

28/02/2023: The following changes were made to the trial record:
1. Protocol uploaded (not peer reviewed).
2. The overall trial end date was changed from 26/03/2014 to 20/11/2017.
17/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/09/2020: Cancer Research UK lay results summary link added to Results (plain English).
16/09/2019: The publication and dissemination plan was updated.
17/07/2018: An intention to publish date has been added.
03/07/2018: No publications found, verifying study status with principal investigator
19/05/2016: Internal review