Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Breast Cancer Clinical Trial

— InForma  

Official title:

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622711
• Other study ID #: IEO 0244
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2020
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Overweight
• Weight Loss

Intervention

Behavioral:
• DI
Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
• PAI
Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
• PADI
Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
• LII
Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Locations

Country	Name	City	State
Italy	IEO Istituto Europeo di Oncologia	Milan

Sponsors (2)

Lead Sponsor	Collaborator
European Institute of Oncology	Associazione Italiana per la Ricerca sul Cancro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight reduction	weight loss =5% of the baseline body weight via calibrated scales, stadiometer	baseline - 6 month
Secondary	Long-term body weight control	long-term weight control or maintenance via calibrated scales, stadiometer	baseline - 12 month - 24 month
Secondary	Pedometer Step Count	change in total step count via pedometer device with electronic data transmission	baseline - 6 month - 12 month - 24 month
Secondary	Physical activity level	change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire	baseline - 6 month - 12 month - 24 month
Secondary	Dietary intake	change in dietary intake via Food Frequency Questionnaire	baseline - 6 month - 24 month
Secondary	Quality of life	change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)	baseline - 6 month - 12 month - 24 month
Secondary	Mood	change in mood via State-Trait Anxiety Inventory (STAI) questionnaires	baseline - 6 month - 12 month - 24 month
Secondary	Lipid Marker Change	change in LDL, HDL, triglycerides and cholesterol assessed by blood samples	baseline - 6 month - 24 month
Secondary	Oestradiol level	change in oestradiol assessed by blood samples	baseline - 6 month - 24 month
Secondary	Insulin level	change in insulin assessed by blood samples	baseline - 6 month - 24 month
Secondary	Glucose level	change in glucose assessed by blood samples	baseline - 6 month - 24 month
Secondary	C-reactive protein level	change in C-reactive protein assessed by blood samples	baseline - 6 month - 24 month