Pain after radiation treatment for cancer cervix

Not yet recruiting

• Conditions: Malignant neoplasm of cervix uteri, unspecified,

• Registration Number: CTRI/2019/06/019675
• Lead Sponsor: No funding

Brief Summary

Cervical cancer is the second most common oncological morbidity in women in India after

breast cancer.Patients undergo various treatment modalities including surgery,

chemotherapy and radiation therapy which includes external beam radiation therapy and

brachytherapy. Locally advanced cervical cancer (LACC) constitutes approximately 70% of all the

cervical cancers for which the definitive treatment is chemo-radiation. Radical radiation therapy,

including brachytherapy, forms the mainstay of treatment in LACC. Brachytherapy involves radiation

treatment by placing the radioactive sources into the utero-cervico-vaginal cavity for cervical

cancers. The procedure involves insertion of an intra-cavitary applicator (ICA) under

anaesthesia and adequate analgesia. The steps include examination under anaesthesia, bladder

catheterization, dilatation of cervical canal, sounding of utero-cervical canal, placement of the

intra-cavitary brachytherapy applicator system and vaginal packing. The brachytherapy

applicator system has intrauterine tandem and intravaginal components in the form of ring or

ovoids, so that high doses of radiation are delivered to the cervix/ tumor while relatively

sparing neighbouring pelvic organs.

After recovery from the procedure, the patient receives parenteral analgesics and is transferred

for imaging, treatment planning and delivery. After brachytherapy completion, the applicators

are removed under adequate analgesia. Inadequate analgesia during the procedure may lead to

poor patient compliance, suboptimal evaluation, & applicator placement, inadequate vaginal

packing and inability to place the applicator which could adversely affect morbidity and local

control of disease. Various techniques for minimising discomfort during ICA placement

include general anaesthesia, regional anaesthesia (spinal, epidural, caudal and paracervical

blocks) and sedation with or without local anaesthesia.

The current standard of care in our institute is to perform ICA placement under general

anaesthesia with systemic analgesics to address the post-procedure pain. Less than 5% of

patients may undergo the procedure under spinal anaesthesia, sedation and/or paracervical

block due to systemic factors which make them high-risk for general anaesthesia

The aim of this study is to observe the incidence and severity of post-procedure pain in patients

undergoing ICA procedures, and to look at the need of supplementary analgesics post

procedure and to compare the severity of pain in different groups of patients such as naive ICA

placements and consecutive ICA placements.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Adult females (more than 18 years) ASA 1,2,3 Cervical cancer patients undergoing intra-cavitary brachytherapy applications.

Exclusion Criteria

Refusal of consent Cognitive dysfunction or psychiatric illness Procedures other than standard ICA (e.g., implants or examination under anaesthesia).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score on numerical rating scale of 0 to 10	30 minutes, 1 hour and 2 hours after completion of brachytherapy procedure

Secondary Outcome Measures

Name	Time	Method
Need for rescue analgesia	within 2 hours after brachytherapy procedure
To compare pain scores between patients having first brachytherapy versus subsequent brachytherapies	within 2 hours after procedure

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Priya Ranganathan

Principal investigator

022-24177000

drpriyaranganathan@gmail.com