Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorCase Comprehensive Cancer Center
About this trial
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 and older
Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or
Patients with diagnosis of pancreatic adenocarcinoma (PDAC) (Stage I, II, or III) undergoing neoadjuvant chemotherapy.
Patients with locally advanced esophageal cancer undergoing neoadjuvant chemotherapy.
Disqualifiers
Life expectancy less than 3 months in the opinion of the treating physician
Patients unable to provide informed consent.
Wheelchair bound patients/ physical immobility.
Severe cardiopulmonary disease defined as NYHA class III or IV
Trial design
Design model
Parallel
Treatments tested in this trial
Prehabilitation
Other interventionExercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training. Nutrition Intervention: 30 gm protein supplement Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and music therapy
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Intervention - Arm 1Experimental treatment 1 intervention
Group B: Control - Arm 2No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of adherence as calculated by the compliance percentage
Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study.
Time frame
6 weeks post interventionSecondary outcomes
1
Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test
Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength
Time frame
Baseline, 6 weeks post intervention2
Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test.
At baseline, and within the immediate post-exercise recovery, rating of perceived exertion (RPE; Borg scale, 6-20) will be assessed. Peak exercise exhaustion was verified if two or more of the following criteria were met: 1)96 HR within 10 bpm of age-predicted maximum HR (220-age), 2) RPE \> 17, and/or 3) a plateau in HR (\<3 bpm change over the last two intensity stages). VO2 max will be calculated by ACSM's Treadmill Walking Equation: VO2 \[ml/kg/min\] = (0.1 x speed) + (1.8 x Speed x Grade) 3.5 ml/kg/min
Time frame
Baseline, 6 weeks post intervention3
Change in effectiveness of prehabilitation as assessed by timed up and go test
Timed up and go test is one unit of time to measure how fast patients can move
Time frame
Baseline, 6 weeks post intervention4
Change in effectiveness of prehabilitation as assessed by grip strength test
Grip strength test measured by handheld dynamometer
Time frame
Baseline, 6 weeks post interventionSponsors and contacts
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Source ClinicalTrials.gov