1-3기 유방암 과체중/비만 환자의 체중 감소를 위한 췌장 영양 프로그램
췌장 영양 프로그램(PNP): 과체중/비만 유방암 생존자를 위한 새로운 체중 감소 프로그램
This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To estimate the change in body weight at 6 months post-intervention relative to baseline.
SECONDARY OBJECTIVES:
I. To examine changes in: body composition; body chemistry; physical fitness; inflammatory markers; deoxyribonucleic acid (DNA) repair capacity; and quality of life per the Functional Assessment of Cancer Therapy - Breast (FACT-B)+4, version 4 questionnaire at 6 months post-intervention relative to baseline.
II. To describe adverse events possibly related to wearing the glucometer sensor or following the pancreatic nutritional program (PNP) diet.
III. To document compliance with the various components of the PNP (wearing the glucometer sensor; recording body weight; completing journal entries; completing meal cards; attending weekly counseling sessions with diet instructor).
OUTLINE:
Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks.
After completion of study, patients are followed up within 1 week and then at 6 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with early-stage breast cancer (stage I-III)
- Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
- Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- Body mass index (BMI) of 25-33 kg/m^2
- Patients must be willing to adhere to the PNP intervention and the entire 6-month study
- All patients must have the ability and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who are diabetic
- Patients whose BMI falls outside the eligible range (< 25 kg/m^2 or > 33 kg/m^2)
- Patients with stage IV breast cancer
- Patients with Rheumatoid Arthritis and other inflammatory diseases that would impact correlative studies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Supportive care (PNP)
Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks. |
Correlative studies Ancillary studies
다른 이름들:
Participate in the PNP
다른 이름들:
Participate in the PNP
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in body weight
기간: Baseline to 6 months
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Tested using the paired t-test, alpha = 0.05. |
Baseline to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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삶의 질 점수 변화(FACT-B+4)
기간: 기준선에서 6개월
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기준선에서 6개월
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규정 준수 지표(혈당 측정기 센서를 사용하지 않은 일수, 체중을 기록하지 않은 일수, 저널 항목을 작성하지 않은 일수, 식사 카드를 만들지 않은 일자, 주간 상담 세션을 놓친 날)
기간: 12주
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12주
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PNP 다이어트 후 혈당계 센서 착용과 관련이 있거나 확실히 관련이 있다고 보고된 이상 반응의 발생률
기간: 최대 6개월
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최대 6개월
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Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance)
기간: Baseline to up to 6 months
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Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to up to 6 months
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Change in body composition (BMI)
기간: Baseline to up to 6 months
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Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to up to 6 months
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Change in physical fitness (measured using a handgrip dynamometer)
기간: Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
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Change in serum inflammatory markers (C-reactive protein; cytokines)
기간: Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
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DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci)
기간: Baseline to 6 months
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Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joanne Mortimer, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 14253
- 14253 (기타 식별자: City of Hope Medical Center)
- NCI-2015-00654 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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