Weight loss to support breast cancer survival

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN12000313
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-15
• Study Completion: 2024-02-24
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

1. Diagnosis of invasive breast cancer within 14 months prior to trial registration
1.1. Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical (cTNM) stage prior to therapy or pathologic (pTNM) stage at surgery; if patient is eligible based on either, they are eligible for the study as long as they do not have T4 disease prior to therapy
1.2. Bilateral breast carcinoma is allowed provided diagnoses are within 3 months of one another and at least one of the two breast carcinomas meet the eligibility criteria, and neither are Her-2 positive or inflammatory
2. HER-2 Negative as defined for the purpose of treatment.
3. Eligible tumour-node-metastasis (TNM) Stages include:
3.1. Oestrogen receptor (ER) and Progesterone receptor (PR) negative: T2 or T3 N0, T0-3N1-3
3.2. ER and/or PR positive: T0-3N1-3 or T3N0
ER and PR status is as defined for the purpose of treatment
4. Patients must have had a bilateral mammogram within 14 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Patients with bilateral total mastectomies do not require imaging).
5. All triple negative patients must receive chemotherapy of the treating clinician’s recommendation.
6. ER/PR positive patients must receive chemotherapy (of the treating physician’s choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone.
7. All adjuvant or neoadjuvant chemotherapy and radiation completed at least 21 days prior to registration. Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable.
8. Surgical margins should be clear, with no tumour at ink for invasive, ductal in situ disease, and pleomorphic lobular carcinoma. Grossly positive margins should be re excised. Focally positive margins (<4mm) should ideally be re excised if technically possible but if not, consideration of radiotherapy boost should be given. Classical LCIS at the margin does not warrant re excision.
9. All surgery completed at least 3 months prior to registration. (Patients may have breast reconstruction during protocol participation, if scheduled for more than 6 months after registration into the trial).
10. Participants must be women
11. Capacity to provide informed consent
12. Aged =18 years at time of trial screening
13. Have a self-reported Body Mass Index of 27.0 – 45.0 kg/m² at time of trial screening
14. Have a BMI of 27.0 – 45.0 kg/m² at time of randomisation, using data from e-scales
15. Have sufficient proficiency in English to contribute to the intervention supporting consultations/ten top tips discussion, and complete the data collection required
16. Treated with curative intent
17. The participant is willing to complete the study assessments (questionnaires and anthropometric measures)
18. Participant reports they are able to stand without support to use the weighing scales provided, or has access to scales suitable for people who cannot stand without support

SWAT INCLUSION CRITERIA
All participants recruited into the We Sure Can trial, and who remain as fully participating (i.e., have not fully withdrawn or have died at each time-point where questionnaires are administered (4, 7 and 10-months post host trial randomisation) will be eligible for the SWAT

Exclusion Criteria

1. Currently participating, or have consented to participate in another weight loss or dietary clinical trial. Co-enrolment in some trials involving pharmacologic therapy is allowed if there is no expected impact of the therapy on weight.
2. Unable to participate in a video or telephone call.
3. History of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal carcinoma in situ [DCIS] is permitted)
4. Patients cannot have metastatic breast cancer or inflammatory breast cancer
4.1. If there is a concern for metastatic disease, all investigations (e.g. chest x-ray, staging CT scan, bone scans), have been performed between first histologic diagnosis and registration
5. Patients with triple negative breast cancer are not eligible if they have T1N1mi disease
6. Patients with ER and / or PR positive breast cancer are not eligible if they have T0N0, T1N0, T2N0 or T1N1mi and T2N1mi disease
7. History of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic cancer at any site.
8. Refusal of breast cancer treatment that has been recommended by the treating clinician. However, where it has been a shared decision not to follow treatment (i.e. due to borderline risk), women are eligible.
9. Current or historic diagnosis of an eating disorder
10. Taking antipsychotic medication
11. Patients who have required hospitalization for depression, have unstable/untreated major depression, active severe depression or bipolar disorder or personality disorder, and any other mental illness at a severity which would prevent participation in an organised weight loss programme and for giving informed consent.
12. Heart failure
13. Type I or Type II diabetes if prescribed any anti-diabetic medication other than metformin
14. Diabetes Insipidus
15. Taking Warfarin
16. Hypertension if prescribed more than one anti-hypertensive drug
17. Lactose intolerance
18. Vegan
19. Alcohol dependence
20. Dependence on substances other than tobacco
21. Taking any anti-obesity medication
22. Had bariatric surgery or scheduled bariatric surgery
23. Experienced a heart attack or stroke in the past 3 months
24. Taking monoamine oxidase inhibitor (MAOI) medication
25. History of malabsorption and/or serious digestive problems, including inflammatory bowel disease and chronic diarrhoea
26. Angina, atrial fibrillation, arrhythmia, or prolonged QT syndrome
27. Renal failure
28. Epilepsy
29. Active liver disease (except non-alcoholic fatty liver disease (NAFLD)), a history of hepatoma or within 6 months of onset of acute hepatitis
30. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer; maintenance treatment with acid suppression is not a contraindication
31. Porphyria
32. Scheduled for any surgery (including breast reconstruction) within 6 months from registration
33. Oxygen-dependent pulmonary disease
34. Sleep apnoea requiring CPAP
35. Pregnant, breastfeeding, or within 4 months post-partum and not breastfeeding
36. Undergoing fertility treatment
37. Under investigation for any of the conditions that have been excluded
38. Comorbid conditions that would cause life expectancy of less than 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified