Clinical trial NCT02622711: Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer
Official title: Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
obesity
weight control
exercise and physical fitness
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
First posted: 2015-12-04
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

Detailed description: The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed with a first invasive non-metastatic breast carcinoma histologically confirmed,
* BMI \> 25,
* within 6-month/one year of completion of main cancer treatment,
* being able to participate in the intervention,
* agree to wear the wrist-based activity monitor during the study period,
* agree to be randomized to either group,
* written informed consent.

Exclusion Criteria:

* severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period,
* contraindications to exercise due to history of heart condition, stroke, chest pain during activity or rest, severe hypertension
* orthopaedic disability that would prevent optimal participation in the physical activities prescribed,
* patient is unable to find transportation to the study location over the study period, - or
* plans to move away from Lombardy or to be out of town for more than 3 weeks during the study period.

Primary outcomes:
measure: Body weight reduction
timeFrame: baseline - 6 month
Secondary outcomes:
measure: Long-term body weight control
timeFrame: baseline - 12 month - 24 month
measure: Pedometer Step Count
timeFrame: baseline - 6 month - 12 month - 24 month
measure: Physical activity level
timeFrame: baseline - 6 month - 12 month - 24 month
measure: Dietary intake
timeFrame: baseline - 6 month - 24 month
measure: Quality of life
timeFrame: baseline - 6 month - 12 month - 24 month
measure: Mood
timeFrame: baseline - 6 month - 12 month - 24 month
measure: Lipid Marker Change
timeFrame: baseline - 6 month - 24 month
measure: Oestradiol level
timeFrame: baseline - 6 month - 24 month
measure: Insulin level
timeFrame: baseline - 6 month - 24 month
measure: Glucose level
timeFrame: baseline - 6 month - 24 month
measure: C-reactive protein level
timeFrame: baseline - 6 month - 24 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO Istituto Europeo di Oncologia
Study officials:
affiliation: European Institue of Oncology
name: Patrick Maisonneuve
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnagnarella P, Draga D, Baggi F, Simoncini MC, Sabbatini A, Mazzocco K, Bassi FD, Pravettoni G, Maisonneuve P. Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials. 2016 Jul 28;17:363. doi: 10.1186/s13063-016-1487-x.