Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

ConditionGynecologycal Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age50+

SponsorWake Forest University Health Sciences

About this trial

The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and willingness to sign an IRB-approved informed consent

Age ≥50 years at the time of enrollment

Newly diagnosed or suspected FIGO Stage II-IV ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype OR FIGO Stage II-IV endometrial carcinoma of any histological subtype

Planned, standard of care treatment consisting of neoadjuvant chemotherapy, tumor reduction surgery, and adjuvant chemotherapy OR tumor reduction surgery with adjuvant chemotherapy

Disqualifiers

Previously treated for ovarian or endometrial cancer

History of brain metastases, whole brain irradiation, poorly controlled psychiatric disorders defined by hospitalization within the last 3 months for psychiatric diagnoses, traumatic brain injury, cerebrovascular event, or dementia

Currently taking anti-amyloid agents, cholinesterase inhibitors, or glutamate regulator

Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study

Trial population

Participants with a suspected or confirmed diagnosis of ovarian, primary peritoneal, fallopian tube, or endometrial cancer with planned standard of care treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

muscle sample
Diagnostic test
For participants undergoing standard of care interval cytoreductive surgery via laparotomy, a skeletal muscle biopsy from the rectus abdominis muscle (1 cm x 1 cm x 1 cm, \~300 mg) will be collected. For participants who undergo standard of care interval cytoreductive surgery with a laparoscopic approach, a skeletal muscle biopsy will be taken from either the rectus abdominis (1 cm x 1 cm x 1 cm, \~300 mg) or the psoas (1 cm x 0.5 cm x 0.5 cm, \~200 mg) muscle.
blood draw
Other intervention
A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Advanced gynecological cancers2 interventions

Trial outcomes

Primary outcomes

Screening rate

Proportion of approached patients who signed consent out of the total number of patients who were approached

Time frame

Screening

Enrollment rate

Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants

Time frame

Screening and pretreatment

Completion rate

Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

Study Feasibility

≥80% enrollment rate, ≥80% completion rate (30 of 37)

Time frame

Screening and up to 30 days following the completion of adjuvant chemotherapy

Secondary outcomes

Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a)

The PROMIS Fatigue 7a is a validated seven-item questionnaire assessing fatigue severity and its impact on daily activities during the past 7 days. Each item is rated on a 5-point scale. Raw scores range from 7 to 35, with higher scores indicating greater fatigue.

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

Short Physical Performance Battery (SPPB)

The SPPB is a measure of lower-extremity physical function consisting of three components: walking speed, repeated chair stands, and standing balance in three increasingly difficult positions.

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

Gait Speed

Walking speed is assessed by asking the participants to walk at their usual pace over a 4-meter course. Walking speed is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

Chair stand tests

The time to complete the task will be recorded. Repeated chair stands is scored from zero to four, with four indicating the highest level of performance and zero indicating an inability to complete the task.

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

Other outcomes

Expression of proteins involved in mitochondrial bioenergetic activities in PBMCs

Protein expression related to electron transport chain activity-including components of the Krebs cycle, fatty acid oxidation, and antioxidant pathways-was measured using proteomics in PBMCs

Time frame

Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

Expression of proteins involved in electron transport chain activities in muscle tissue

Protein expression related to electron transport chain activity-including components of the Krebs cycle, fatty acid oxidation, and antioxidant pathways-was measured using proteomics in muscle tissue

Time frame

Cytoreductive Surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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