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POSITIVE - Study (Part III) Heidelberg (POSITIVE)

2018년 8월 22일 업데이트: German Cancer Research Center

Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment

The investigators plan to evaluate, in a randomized, controlled phase III trial in patients with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise intervention program (EIP) on quality of life, physical functioning and immune function parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases, Heidelberg, over a time period of two years and followed up for a total of 12 months.

Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential influence of social contacts that can be anticipated for the patients in the intervention group).

Our primary aims are to investigate whether a combination of a partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life (QoL) and lowers levels of fatigue (evaluation via the standardized and validated questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on tumor specific immune responses. Biomarkers of immune function will be measured by cellular immunity and cytokine and chemokine panels.

Further secondary outcomes include measurement of anxiety, depression and demoralization, physical performance parameters (e.g. improvement in walk distance, muscle strength), as well as overall and progression free survival analyses.

The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in patients with advanced NSCLC with the results being utilized in the design of the here proposed trial.

The investigators hypothesize that patients randomized in the exercise intervention group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

232

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, 독일, 69126
        • Thoracic Oncology Clinic for Thoracic Diseases

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • NSCLC stage IIIB/IV
  • receiving systemic treatment (palliative radiotherapy accepted)
  • BMI > 18
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  • signed informed consent

Exclusion Criteria:

  • serious active infection (i.e. requiring an iv antibiotic, antifungal or antiviral agent)
  • inability to walk
  • immobility (more than two days)
  • previously untreated (non-irradiated or non-resected) symptomatic brain metastases;permitted are: (1) previously treated brain metastases [radiotherapy, surgery, dexamethasone dosage 8 mg per day, anti-epileptic therapy]; (2) asymptomatic brain metastases without additional therapy requirement
  • severe neurologic impairment (e.g. apoplectic insult, Morbus Parkinson, pareses of extremities)
  • severe cardiac impairment (e.g. cardiac insufficiency NYHA (New York Heart Association) > III, myocardial infarction within the last three months, unexplained syncopal events, severe cardiac arrhythmias, high grade aortic stenosis)
  • severe respiratory insufficiency
  • uncontrolled pain
  • abuse of alcohol or drugs reducing compliance to the study
  • bone metastasis inducing skeletal fragility
  • any circumstance that would impede ability to give informed consent or adherence to study requirements.

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Exercise Intervention Program (EIP)

Inpatient periods: The combined resistance and endurance program consist of free weight and rubber band training for major upper and lower body muscle groups respectively of cycling/walking on an ergometer/treadmill 3x/week.

Outpatient periods (3x/week at least two/one supervised training sessions): Supervised training sessions in the local outpatient training center will comprise of resistance exercise on machines and endurance training on an ergometer/treadmill. For non-supervised training session during the outpatient period participants will receive an exercise manual for individualized home-based exercising.

In weekly phone calls, the advanced practice nurse will review adherence to the intervention and identify problems. Furthermore, the patients will also be asked the same questions as in the CMPC group.
행동: 운동 중재
다른: Care-Management-Phone-Calls
활성 비교기: Care-Management-Phone-Calls (CMPC)
Patients in this arm will receive a weekly "care-management-phone-call" (CMPC), performed by an advanced practice nurse (APN). The CMPCs are based on a structured questionnaire, reflecting pain, shortness of breath, disturbed sleep, exhaustion and distress and potentially treatment related side effects (e.g. infections, polyneuropathy, etc.). In case of demanding management of symptoms or complaints (e.g. uncontrolled pain or breathlessness) the treating physician is contacted by the APN to facilitate improvement.
다른: Care-Management-Phone-Calls

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
QoL: Physical Well-Being (FACT-L)
기간: assessed after 12 weeks of enrolement
The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire comprises of 36 items and deter-mines the quality of life in patients with lung cancer. It is separated in the subcategories "physical well-being" (PRIMARY OUTCOME), "emotional well-being", "social well-being", "functional well-being and disease-specific items". It is widely used in clinical studies and was already applied in exercise intervention studies in lung cancer patients
assessed after 12 weeks of enrolement
General Fatigue (MFI)
기간: assessed after 12 weeks of enrolement
The MFI (Multidimensional Fatigue Inventory) questionnaire (20 items) evaluates the extent of chronic fatigue and is divided into the 5 subscales "general fatigue", "physical fatigue", "mental fatigue", "reduced motivation" and "reduced activity". The MFI questionnaire is widely used in oncological studies and an adequate number of comparative samples exists.
assessed after 12 weeks of enrolement

2차 결과 측정

결과 측정
측정값 설명
기간
Physical Performance (endurance and strength capacity)
기간: assessed every 3 month after enrolement until month 12

6-Minute Walk Test (endurance capacity) The 6 minute walk test is feasible and safe to determine patients physical capacity. Patients are instructed to walk in 6 min. as many meters as possible with oxygen saturation and pulse rate being measured concomitantly.

Hand-held Dynamometry (isometric strength capacity) The hand-held dynamometry is a standardized instrument to measure muscular strength. In the study 6 major muscle groups of upper and lower extremities will be assessed for their isometric power.
assessed every 3 month after enrolement until month 12
Psychosocial Parameters (e.g. depression, anxiety, demoralization)
기간: assessed every 3 month after enrolement until month 12

PHQ(Ultra-Brief Patient Health Questionnaire)-4 :

The PHQ-4 (Ultra-Brief Patient Health Questionnaire) questionnaire is a short instrument comprising of 4 items to detect the extent of depression and anxiety. It provides sufficient diagnostic accuracy for major depression and can be used as a screening instrument in cancer populations.

DS (Demoralization Scale) The demoralization scale (DS) is a relatively new developed questionnaire to detect the extent of existential distress in cancer patients. The German version was validated in 2011 and comprises of 24 questions. The results of the validation showed that the concept of demoralization is a useful instrument to describe the different states of existential distress and the individual incapacity to cope effectively with stressful situations.
assessed every 3 month after enrolement until month 12
Overall survival
기간: for the period of 1 year after enrolement
for the period of 1 year after enrolement
progression-free survival
기간: for the period of 1 year after enrolement
for the period of 1 year after enrolement

기타 결과 측정

결과 측정
측정값 설명
기간
Adverse Events
기간: baseline until 6 month after enrolement
Safety analyses will be based on Adverse Events (AE´s), Severe Adverse Events (SAE´s), and Suspected Unexpected Serious Adverse Reaction (SUSARs) recorded during the study. Of particular interest are AEs, SAEs and SUSARs deemed to be potentially causally related to the endurance and resistance training.
baseline until 6 month after enrolement
Translational Program / Immunology
기간: baseline, 3 & 6 month after enrolement

Quantification (Q) of immune cells: Multicolor flow cytometry from cryopreserved Peripheral Blood Mononuclear Cell (PBMC), CD (cluster of differentiation) 4+ and CD 8+ T cells, effector, naïve and activated T cells, regulatory T cells (Treg) and their functional subsets, natural killer cells, B cells, monocytes and monocyte-derived myeloid suppressor cells will be assessed.

Q. of tumor antigen reactive effector/memory T cells: Will be done by interferon gamma Enzyme Linked Immuno Spot Assays from PBMC using a panel of defined tumor antigens presented by generated autologous dendritic cells as antigen presenting cells and purified T cells as responder cells.

Detection of tumor reactive Treg: Will be done by established Treg specificity assay based on the increased suppressive activity of specifically activated regulatory T cells.

Q. of key immune effector molecules: Will be done for app. 14 different cytokines and chemokines from cryopreserved serum samples.
baseline, 3 & 6 month after enrolement

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

German Cancer Research Center

협력자

University Hospital Heidelberg
National Center for Tumor Diseases, Heidelberg

수사관

  • 수석 연구원: Michael Thomas, Prof. Dr., Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg
  • 수석 연구원: Joachim Wiskemann, Dr., National Center for Tumor Diseases (NCT)
  • 수석 연구원: Simone Hummler, Dr., Thoracic Oncology Clinic for Thoracic Diseases/University of Heidelberg

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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)

2013년 12월 1일

기본 완료 (실제)

2017년 3월 1일

연구 완료 (실제)

2018년 3월 1일

연구 등록 날짜

최초 제출

2013년 12월 12일

QC 기준을 충족하는 최초 제출

2014년 2월 4일

처음 게시됨 (추정)

2014년 2월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 22일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • POSITIVE-III-S-326/2013

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. .

고급 NSCLC에 대한 임상 시험

운동 중재에 대한 임상 시험

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위치

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