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Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03946007
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
J. Nuver, University Medical Center Groningen

Study Description
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Brief Summary:

Rationale: Tremendous anti-tumor effects have been achieved using immune checkpoint inhibitors for melanoma and NSCLC with long lasting responses of more than 2 years in a substantial subgroup of patients. However, we are still largely unaware of the health-related quality of life of these patients. We should carefully and thoroughly assess the long-term burden of disease and treatment toxicity.

Objective: Primary Objective: to investigate health-related quality of life (HRQoL) of patients surviving 2 years or more after the first cycle of an immune checkpoint inhibitor for melanoma or NSCLC. Secondary Objectives: to assess neurocognitive function, endocrine function, cardiovascular risk, physical fitness, mood disorders, sexual problems, work participation in patients surviving 2 years or more after the first cycle of immune checkpoint inhibitor; to assess quality of life of the caregivers of these patients.

Study design: Observational cross-sectional study. Study population: Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both).

Main study parameters/endpoints: health-related quality of life (HRQoL) as measured using the EORTC Quality of life questionnaire (QLQ-C30). Secondary study parameters: possible late effects (neurocognitive dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and infertility, increased cardiovascular risk, and fatigue), physical fitness, psychosocial issues related to work/education, mood disorders (anxiety and depression), patient and treatment-related factors potentially influencing development of late effects, well-being, and quality of life of caregivers.


Condition or disease
Melanoma Non Small Cell Lung Cancer

Detailed Description:
Participation in the study will include one study visit of approximately 2.5 hours. If possible, the study visit will be combined with a regular follow-up visit. Vena puncture is the only invasive procedure, with low risk of adverse effects. Blood will be drawn after an overnight fast. To minimize the duration of the visit, patients will be offered to fill out the questionnaires at home. Individual adverse test results will be reported to a participants' treating physician to enable treatment or follow-up as indicated. The results of the full study group will be used to guide future interventions and support for melanoma and NSCLC patients.
Study Design
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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Quality of Life, Cognitive Function, and Physical Fitness of Melanoma and NSCLC Patients Surviving More Than 2 Years After Immune Checkpoint Inhibitor Therapy
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort
Patients with melanoma or NSCLC
Patients (age ≥18 years) with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.


Outcome Measures
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Primary Outcome Measures :
  1. Health-related quality of life (HRQoL) [ Time Frame: 3 years ]
    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core questionnaire (QLQ-C30)


Secondary Outcome Measures :
  1. cognitive function [ Time Frame: 3 years ]
    Hopkins Verbal Learning Test-Revised (HVLT-R);

  2. cognitive function [ Time Frame: 3 years ]
    Controlled Oral Word Association Test (COWA);

  3. cognitive function [ Time Frame: 3 years ]
    Trail Making Test (TMT)

  4. Physical fitness [ Time Frame: 3 years ]
    six-minute walk test (6MWT)

  5. endocrine function [ Time Frame: 3 years ]
    measurement of gonadal and pituitary function in blood

  6. Quality of life of caregivers [ Time Frame: 3 years ]
    Caregiver Quality of Life Index-Cancer (CQOLC)

  7. muscle strength [ Time Frame: 3 years ]
    Maximal voluntary isometric muscle force of the right and left extremity of extension of the knee, flexion of the knee, flexion of the elbow, extension of the elbow and grip-strength of the hand will be measured using a hand-held dynamometer.


Biospecimen Retention:   Samples With DNA
vena punction

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
An estimated 80 adult patients with advanced melanoma and 250 patients with NSCLC are treated with immune checkpoint inhibitors in the UMCG each year. Around 20% of these patients are expected to survive ≥2 years since their first cycle of immune checkpoint inhibitor. Patients will be recruited and study measurements will be performed within 3 year after start of study. We expect to include 25 melanoma and 50 NSCLC patients per treatment year.
Criteria

Inclusion Criteria:

  1. Patient with melanoma or NSCLC ≥2 years since treatment with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor, PD-(L)1 inhibitor, or both) within the Department of Medical Oncology or Pulmonary Oncology of the UMCG.
  2. Age ≥18 years at time of immune checkpoint inhibitor treatment
  3. All previous or subsequent therapies allowed, including (brain) irradiation, surgery for metastases, chemotherapy, and targeted therapy, provided stable clinical situation at time of inclusion

Exclusion Criteria:

  1. Switch of systemic therapy or local antitumor intervention (surgery, radiotherapy) during last 2 months
  2. Inability to understand or abide to the study protocol
  3. Debilitating psychiatric illness
  4. Previous treatment for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946007


Contacts
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Contact: J. Nuver, MD, PhD +31 50 361 2821 j.nuver@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: J. Nuver, MD, PhD    +31 50 361 2821    j.nuver@umcg.nl   
Principal Investigator: J. Nuver, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: J. Nuver, MD, PhD University Medical Center Groningen
More Information
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Responsible Party: J. Nuver, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03946007    
Other Study ID Numbers: 201800146
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas