Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT

Ovarian Cancer Clinical Trial

Official title:

Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412510
• Other study ID #: CASE3824
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2024
• Est. completion date: February 10, 2025

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Mariam AlHilli, MD
• Phone: 216-644-0418
• Email: alhillm[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 and older

• Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC) undergoing neoadjuvant chemotherapy; OR Patients with diagnosis of pancreatic adenocarcinoma undergoing neoadjuvant chemotherapy

Exclusion Criteria:

• 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

• Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded.

• Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Adenocarcinoma

Intervention

Other:
• Prehabilitation
Exercise 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

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks post intervention
Secondary	Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test	Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength	Baseline, 6 weeks post intervention
Secondary	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	Baseline, 6 weeks post intervention
Secondary	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	Baseline, 6 weeks post intervention
Secondary	Change in effectiveness of prehabilitation as assessed by 6-minute walk test	The 6-minute walk test is measured by the distance walked in 6 minutes	Baseline, 6 weeks post intervention
Secondary	Change in effectiveness of prehabilitation as assessed by grip strength test	Grip strength test measured by handheld dynamometer	Baseline, 6 weeks post intervention
Secondary	Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test	The number of times a patient can rise to a standing position from a seated position without the use of their upper extremities is counted in a thirty second period.	Baseline, 6 weeks post intervention
Secondary	Change in measure of balance as assessed by unipedal stance test	This is a measure of balance and is assessed by asking the participant to stand on one foot (of their choice) with the lifted foot remaining close to their opposite ankle, first with eyes open and then with eyes closed.The amount of time a participant can stand on one foot is recorded.	Baseline, 6 weeks post intervention
Secondary	Effectiveness of prehabilitation as assessed by measuring the change in body mass composition	Body composition measured using contrast-enhanced CT scan	Baseline, 6 weeks post-intervention
Secondary	Effectiveness of prehabilitation as assessed by the change in nutritional status	Assessed for the presence of malnutrition per the Cleveland Clinic organization's standard of care based on American Society for Parenteral and Enteral Nutrition (ASPEN) and the Academy of Nutrition and Dietetics (AND) (ASPEN/AND) guidelines, and by assessing changes in the degree of malnutrition throughout the study period	Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention
Secondary	Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)	Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'	At baseline
Secondary	Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)	Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'	Upto 6 weeks post intervention
Secondary	Quality of life as assessed by FACT-O	FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'	At baseline
Secondary	Quality of life as assessed by FACT-O	FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'	Upto 6 weeks post intervention
Secondary	Effectiveness of prehabilitation as assessed by Chemotherapy toxicity	Chemotherapy toxicity as measured by the standard CTCAE v5 grading system	At cycle 2, day 1(each cycle is 21 days)
Secondary	Effectiveness of prehabilitation as assessed by Chemotherapy toxicity	Chemotherapy toxicity as measured by the standard CTCAE v5 grading system	At cycle 3, day 1(each cycle is 21 days)
Secondary	Effectiveness of prehabilitation as assessed by Chemotherapy toxicity	Chemotherapy toxicity as measured by the standard CTCAE v5 grading system	At cycle 4, day 1(each cycle is 21 days)
Secondary	Effectiveness of prehabilitation as assessed by Chemotherapy toxicity	Chemotherapy toxicity as measured by the standard CTCAE v5 grading system	Upto 6 weeks post intervention
Secondary	Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)	IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.	Upto 6 weeks post intervention
Secondary	Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)	FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.	Upto 6 weeks post surgery
Secondary	Effectiveness of prehabilitation as assessed by participant acceptability scale	Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal	Baseline
Secondary	Effectiveness of prehabilitation as assessed by participant acceptability scale	Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal	Upto 6 weeks post surgery