INTERVAL: Ipilimumab and Nivolumab Combination Therapy: A Study of a Supervised or Semi-Supervised Exercise InteRVention or Usual Care With Functional Capacity and Quality of Life Evaluations in Subjects With Advanced or Metastatic RenAL Cell Carcinoma

Metastatic Renal Cell Carcinoma Clinical Trial

— INTERVAL  

Official title:

INTERVAL: Ipilimumab and Nivolumab Combination Therapy: A Study of a Supervised or Semi-Supervised Exercise InteRVention or Usual Care With Functional Capacity and Quality of Life Evaluations in Subjects With Advanced or Metastatic RenAL Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03692338
• Other study ID #: Pro00082941
• Status: Terminated
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 9, 2019

Study information

• Verified date: December 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to report the effects of immediate or delayed exercise training on patients with advanced or metastatic renal cell carcinoma who are receiving nivolumab and ipilimumab.

Description:

Exercise interventions also have been shown to improve both cancer- and treatment-related fatigue and quality of life across multiple tumor types. Thus, an exercise intervention could improve the tolerability of combination immunotherapy. Furthermore, functional capacity and/or amount of physical activity are associated with survival in several cancers. Finally, there is emerging evidence that exercise training may augment beneficial cancer-specific immune function. This study will examine parallel groups of supervised or semi-supervised exercise training or usual care in patients with mRCC treated with nivolumab and ipilimumab combination therapy. Fitness level will be evaluated by cardiopulmonary exercise testing (CPET), wearable exercise tracking devices and questionnaires after 12 weeks of semi-supervised, home-based exercise.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Scheduled to receive ipilumab and nivolumab as first line of immune checkpoint inhibitor therapy for Renal Cell Carcinoma (RCC).

a. Patient may receive the first infusion of ipilimumab/nivolumab prior to eligibility determination

3. Subjects with brain metastases are allowed if they are asymptomatic, without edema, and not on greater than or equal to 10mg daily dose of systemic corticosteroids or receiving radiation therapy for at least 14 days prior to beginning protocol therapy.

4. Karnofsky Performance Status (KPS) of at least 70%

5. Able to walk on a treadmill per patient report.

6. Ability to understand English and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Major surgery (e.g. nephrectomy) less than 28 days prior to the first dose of ipilimumab/nivolumab.

2. History of cerebrovascular accident including transient ischemic attack (TIA) within the past 6 months.

3. Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator. Note: This criterion must be met prior to CPET.

4. Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training, as determined by the attending oncologist:

• Uncontrolled arrhythmia causing symptoms or hemodynamic compromise

• Recurrent syncope

• Active endocarditis

• Acute myocarditis or pericarditis

• Symptomatic severe aortic stenosis

• Uncontrolled heart failure

• Acute (within 3 months) pulmonary embolus or pulmonary infarction

• Thrombosis of lower extremities

• Suspected dissecting aneurysm

• Uncontrolled asthma

• Pulmonary edema

• Room air desaturation at rest <85%

• Respiratory failure

• Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)

• Mental impairment leading to inability to cooperate.

• Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg].

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Behavioral:
• Exercise
Patients will be asked to complete 3 x 30 minute exercise sessions each week.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiopulmonary function	Change in VO2 peak	Baseline, 13 weeks
Secondary	Patient-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale	The FACIT-F measures severity and impact of fatigue on functioning and health-related quality of life experienced in past seven days using 40 statements that patients are asked to rate as 0-4 with 0 being "Not at all" and 4 being "Very much".	13 weeks
Secondary	Patient-reported activity as measured by the Godin Leisure Time Exercise Questionnaire	The Godin Leisure is a patient-reported outcome tool to measure activity	13 weeks
Secondary	Patient-reported symptoms as measured by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19)	The FKSI-19 is a patient-reported outcome tool to measure symptoms of Cancer	13 weeks
Secondary	Patient health outcome as measured by the EQ-5D health questionnaire	The EQ-5d is a patient-reported outcome tool to measure health	13 weeks
Secondary	Patient-reported activity as measured by the Stanford Brief Activity Survey	The Stanford Brief Activity Survey is a patient-reported outcome tool to measure activity	13 weeks
Secondary	Patient-reported activity as measured by the Incidental and Planned Activity Questionnaire	The Incidental and Planned Activity Questionnaire is a patient-reported outcome tool to measure activity	13 weeks