Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01302379

Enrollment

333

Registered

2011-02-24

Start date

2011-08-31

Completion date

2016-12-31

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Obesity, Survival, Weight loss, Metformin, Biological markers

Brief summary

This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.

Interventions

DRUGMetformin

Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time

DRUGPlacebo

Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time

BEHAVIORALLifestyle intervention

Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.

BEHAVIORALStandard printed dietary guidelines

Set of standard health education materials provided to participants at single time point (immediately after randomization)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Main effects of the factorial design were the planned primary analysis and what the study was powered on.

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* BMI at least 25.0 kg/m2 * Diagnosed with Stage I, II, or III breast cancer within past 5 years * Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation * Not scheduled for or currently undergoing chemotherapy * Accessible geographically and by telephone * Able to communicate dietary and physical activity data via telephone * If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period * Post-menopausal at diagnosis

Exclusion criteria

* Preliminary bloodwork outside of specified ranges * Evidence of renal insufficiency, liver disease, or congestive heart failure * Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams) * Recent initiation (\< 3 months ago) of thiazides or β-blockers * Taking insulin or other antidiabetic drug * Other primary or recurrent invasive cancer in past 10 years * Unable to commit to study requirements

Design outcomes

Primary

Measure	Time frame	Description
Insulin	change from baseline to 6 months	Insulin measured as percent change from baseline
Glucose	change from baseline to 6 months	Glucose measured as percent change from baseline
C-reactive Protein	change from baseline to 6 months	C-reactive protein measured as percent change from baseline
Bioavailable Testosterone	change from baseline to 6 months	Bioavailable testosterone measured as percent change from baseline
Serum Hormone Binding Globulin	change from baseline to 6 months	Serum hormone binding globulin measured as percent change from baseline

Countries

United States

Participant flow

Participants by arm

Arm	Count
Metformin + Lifestyle Intervention Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.	83
Placebo + Lifestyle Intervention Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.	83
Metformin + Standard Dietary Guidelines Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)	84
Placebo + Standard Dietary Guidelines Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)	83
Total	333

Baseline characteristics

Characteristic	Metformin + Lifestyle Intervention	Placebo + Lifestyle Intervention	Metformin + Standard Dietary Guidelines	Placebo + Standard Dietary Guidelines	Total
Age, Continuous	62.1 years STANDARD_DEVIATION 7.1	62.9 years STANDARD_DEVIATION 62.1	62.1 years STANDARD_DEVIATION 6.3	63.1 years STANDARD_DEVIATION 7.4	62.6 years STANDARD_DEVIATION 6.9
Body Mass Index	31.4 kg/m2 STANDARD_DEVIATION 5.2	30.8 kg/m2 STANDARD_DEVIATION 4.6	30.8 kg/m2 STANDARD_DEVIATION 4.7	31.5 kg/m2 STANDARD_DEVIATION 5.4	31.1 kg/m2 STANDARD_DEVIATION 5
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	12 Participants	4 Participants	12 Participants	38 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants	71 Participants	80 Participants	71 Participants	294 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Asian	3 Participants	0 Participants	1 Participants	2 Participants	6 Participants
Race/Ethnicity, Customized Black or African American	3 Participants	2 Participants	5 Participants	2 Participants	12 Participants
Race/Ethnicity, Customized Mixed Race or Other race	8 Participants	13 Participants	8 Participants	9 Participants	38 Participants
Race/Ethnicity, Customized White	69 Participants	68 Participants	70 Participants	70 Participants	277 Participants
Sex: Female, Male Female	83 Participants	83 Participants	84 Participants	83 Participants	333 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Time Since Diagnosis	2.4 years STANDARD_DEVIATION 1.9	3.1 years STANDARD_DEVIATION 2.4	2.6 years STANDARD_DEVIATION 1.9	2.5 years STANDARD_DEVIATION 1.7	2.7 years STANDARD_DEVIATION 2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 333	1 / 333
serious Total, serious adverse events	5 / 333	5 / 333

Outcome results

Primary