Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Mary Pegington


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

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:

Ethics approval

NRES Committee North West - Greater Manchester West, 04 April 2012, ref: 12/NW/0230

Study design

Randomised interventional and observational trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast


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



Not Applicable

Drug names

Primary outcome measures

Weight, body fat (DXA, impedence), waist and hips measured twice at baseline and post chemotherapy appointments

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

UK Sample Size: 170

Participant 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 X–ray, 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
M23 9LT
United Kingdom

Sponsor information


University Hospital of South Manchester (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Breast Cancer Research Trust (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/05/2016: Internal review