Lactation Outcomes Among Survivors of Pediatric Cancer

Cancer Clinical Trial

Official title:

Lactation Outcomes Among Survivors of Pediatric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399956
• Other study ID #: LACOUT
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: December 8, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.

Description:

Participants will complete a cross-sectional survey. Responses will be compared with a national sample of healthy women from Project First (Infant Feeding Practices Survey II).

Primary Objective:

• To describe breastfeeding outcomes (intention, initiation, duration, and weaning) among female SJLIFE protocol participants 18 years of age and older who reported a live birth.

Secondary Objective:

• To compare breastfeeding outcomes between childhood cancer survivors and healthy mothers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.

• Female

• 18 years of age or older

• At least one reported live birth after childhood cancer diagnosis and treatment.

Exclusion Criteria:

• Unable to read and write.

• Unable to read and understand English.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Leukemia

Intervention

Other:
• Survey
Those who agree to participate will complete a cross-sectional survey on lactation outcomes (LACOUT). Eligible participants who consent to our study will complete the LACOUT questionnaire. The questionnaire uses the same breastfeeding measures as the CDC's Project First surveys and adds 21 items that are specific to the participant's cancer treatment and current health status.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of survivors who experience successful breastfeeding outcome by age at diagnosis		Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by years since diagnosis	Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth.	Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by therapy with radiation		Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by therapy with surgery	Includes chest and/or brain surgery.	Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency	Growth hormone deficiency indicated by low IGF-1	Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism	Hypothyroidism, primary or central, measured by TSH level.	Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus		Once, at enrollment (Day 1)	No
Primary	Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity	Obesity (BMI) prior to pregnancy.	Once, at enrollment (Day 1)	No
Secondary	Number of survivors who experience successful breastfeeding outcome compared to healthy women	Breastfeeding outcomes (intention, initiation, and duration/weaning) will be determined by self-report, and dichotomized for analysis. Intention is defined as a mother's specific plan to breastfeed her infant prior to birth (yes/no); initiation is defined as ever having started breastfeeding (yes/no); duration is defined as at least 6 months of breastfeeding (yes/no); and weaning is defined as breastfeeding cessation after 1 year (yes/no).; Data from survivors will be compared with a national sample of healthy women (n=2,000) who responded to the Project First survey (2009). The Infant Feeding Practices Survey II (Project First) is a longitudinal study developed by the Food and Drug Administration and the Centers for Disease Control and Prevention.	Once, at enrollment (Day 1)	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital