Testing two interventions to reduce the time needed to recover after surgery for ovarian cancer.

Not Applicable

Recruiting

• Conditions: Ovarian cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12618002029279
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-18
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women aged 18 and older with suspected advanced malignancy of the ovary/fallopian tube or peritoneum.
2. Disease suspected to be at least Stage III disease at initial diagnosis.
3. Planned to undergo laparotomy (primary surgery or after neoadjuvant chemotherapy of a maximum 4 cycles of chemotherapy).
4. Adequate renal function (e.g. creatinine clearance greater than 50 ml/min).
5. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
6. Signed, written informed consent.

Exclusion Criteria

1. History of uncontrolled insulin-dependent diabetes mellitus.
2. Uncontrolled gastro-oesophageal reflux disease or disorders of gastric emptying.
3. Intestinal obstruction
4. Known allergy to pregabalin or to any ingredients of the Nutricia pre-op drink.
5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
6. Pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of the study interventions by measuring adherence to allocated treatment via direct supervision. [For intervention 1 assessed at 2 hours prior to surgery and for intervention 2, 1 hour prior to surgery and then 12 hours following the first dose. ]