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NCT Number: NCT03946007

Quality of Life and Physical Fitness After Immune Checkpoint Inhibitors

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.

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Key information

Conditions

Melanoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age ≥18 years at time of immune checkpoint inhibitor treatment
  • 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

  • Switch of systemic therapy or local antitumor intervention (surgery, radiotherapy) during last 2 months
  • Inability to understand or abide to the study protocol
  • Debilitating psychiatric illness
  • Previous treatment for malignancy other than melanoma (excluding non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or carcinoma in situ of breast)

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Quality of Life, Cognitive Function, and Physical Fitness of Melanoma and NSCLC Patients Surviving More Than 2 Years After Immune Checkpoint Inhibitor Therapy

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 10, 2019
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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