Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients (SUPPORT)
2026년 6월 8일 업데이트: University of Erlangen-Nürnberg Medical School
SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids/ Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients
Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.
In addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.
The aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
288
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Bavaria
-
Erlangen, Bavaria, 독일, 91056
- 모병
- Hector-Center for Nutrition, Exercise and Sports
-
연락하다:
- Prof. Dr. med. Yurdagül Zopf
- 전화번호: 0049091318545220
- 이메일: yurdaguel.zopf@uk-erlangen.de
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages
- Women and men aged 18 years or older
- ECOG performance status 0-2
Exclusion Criteria:
- Patients younger than 18 years
- Bone metastases or skeletal involvement associated with a high risk of fracture
- Pregnant or breastfeeding women
- Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent
- Participation in other exercise and/or nutritional intervention studies within the previous 3 months
- Current use of fish oil supplements
- Severe cardiovascular disease, NYHA class IV
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo, no training
Placebo (corn oli) and no training program
|
4x capsueles daily
|
|
위약 비교기: Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
|
4x capsueles daily
2x weekly resistance training
|
|
실험적: Omega-3, no training
Verum (Omega-3-capsules with fish oil) and no training program
|
4x capsules containing 500 mg EPA and 250 mg DHA
|
|
실험적: Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
|
2x weekly resistance training
4x capsules containing 500 mg EPA and 250 mg DHA
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Skeletal Muscle Status I
기간: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Body composition: BIA (SMM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status II
기간: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status III
기간: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status IV
기간: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Handgrip strength: dynamometer (in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance I
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Functional exercise capacity: 6-minute walk test (distance in m)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance II
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance III
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Accelerometry over 7 consecutive days (steps)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status I
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) [0 (no risk) - 7 (highest risk)]
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status II
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status III
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Dietary intake and nutrient analysis: 3 or 7-day dietary record and assessment of consumption of EPA- and DHA-rich foods, and omega-3/omega-6 fatty acid ratio (in g)
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-Reported Outcomes I
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes II
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale [0-52, higher scores indicate better quality of life and less severe fatigue]
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes IV
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Omega-3-Index
기간: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 1일
기본 완료 (추정된)
2028년 10월 1일
연구 완료 (추정된)
2029년 10월 1일
연구 등록 날짜
최초 제출
2026년 1월 14일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 1월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- SUPPORT-Study
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
-
Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Society for Endocrinology초대로 등록
-
Jonsson Comprehensive Cancer Center모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국