## Protocol Section
### Identification Module
**NCT ID:** NCT02836379

**Acronym:** CAVIDIOR

**Brief Title:** Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

**Official Title:** Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

#### Organization Study ID Info
**ID:** ANG-DOL-2016-01 (CAVIDIOR)
#### Organization
**Class:** INDUSTRY
**Full Name:** Angelini Farmacéutica
### Status Module
#### Completion Date
**Date:** 2018-02-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-05

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-11

**Type:** ACTUAL

#### Start Date
**Date:** 2016-07-08

**Type:** ACTUAL

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2016-07-19
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-11
**Study First Submit QC Date:** 2016-07-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Angelini Farmacéutica

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances.

In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment.

This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals.

### Conditions Module

**Conditions:**

- Breakthrough Pain

**Keywords:**

- Breakthrough Cancer Pain

- Quality of life

- Radiotherapy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 79

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** No intervention (Non-interventional study)

**Intervention Names:**

- Other: No intervention

**Label:** Breakthrough Cancer Pain

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Breakthrough Cancer Pain

**Description:** No intervention

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.

**Measure:** Change in quality of life according SF-12 questionnaire

**Time Frame:** Baseline and 4-6 weeks (estimated end of radiotherapy treatment)

#### Secondary Outcomes

**Description:** Percentage of patients with neuropathic, visceral, somatic and mixed pain

**Measure:** Percentage of patients with neuropathic, visceral, somatic and mixed pain

**Time Frame:** Baseline (the day that patient sign the informed consent form)

**Description:** Percentage of patients with each comorbidity

**Measure:** Comorbidities associated with patients

**Time Frame:** Baseline (the day that patient sign the informed consent form)

**Description:** Time from the start of the episode until the relief of breakthrough pain

**Measure:** Mean time to relief of breakthrough pain

**Time Frame:** Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment

**Description:** Time from the start of the episode until the pain ends

**Measure:** Mean duration of the episodes of breakthrough pain

**Time Frame:** Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment

**Description:** Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale

**Measure:** Clinical Global improvement

**Time Frame:** 4-6 weeks (estimated end of radiotherapy treatment)

**Description:** Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale

**Measure:** Patient Global improvement

**Time Frame:** 4-6 weeks (estimated end of radiotherapy treatment)

**Description:** Difference in percentage of patients with punctuation ≥ 17 points at end of radiotherapy treatment and baseline.

**Measure:** Change in assessment (percentage) of family claudication

**Time Frame:** Baseline and 4-6 weeks (estimated end of radiotherapy treatment)

**Description:** Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.

**Measure:** Change in mean Intensity of breakthrough cancer pain at each study visit

**Time Frame:** Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment

**Description:** Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline

**Measure:** Change in MOS Sleep Scale scores

**Time Frame:** Baseline and 4-6 weeks (estimated end of radiotherapy treatment)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients \> 18 years
* Cancer Patients
* Patients attended in radiation oncology consultations with palliative intent
* Life expectancy \> 6 months
* Written informed consent
* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm

Exclusion Criteria:

* Untreated patients with opioids for baseline pain
* Patients who are not opioid tolerant
* Serious psychiatric disorder or any disease or condition that prevents the collection of data
* Patients with evidence of opioid addiction or history of drug or alcohol abuse

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Santiago de Compostela

**Country:** Spain

**Facility:** Complejo Hospitalario Universitario de Santiago

**State:** A Coruña

**Zip:** 15706

**Location 2:**

**City:** Terrassa

**Country:** Spain

**Facility:** Hospital de Terrassa

**State:** Barcelona

**Zip:** 08227

**Location 3:**

**City:** Majadahonda

**Country:** Spain

**Facility:** Hospital Puerta de Hierro

**State:** Madrid

**Zip:** 28222

**Location 4:**

**City:** Vigo

**Country:** Spain

**Facility:** Hospital Do Meixoeiro

**State:** Pontevedra

**Zip:** 36200

**Location 5:**

**City:** A Coruña

**Country:** Spain

**Facility:** Centro Oncológico de galicia

**Zip:** 15009

**Location 6:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de l'Esperança

**Zip:** 08024

**Location 7:**

**City:** Barcelona

**Country:** Spain

**Facility:** ICO Hospitalet

**Zip:** 08908

**Location 8:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Ramón y Cajal

**Zip:** 28034

**Location 9:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital La Paz

**Zip:** 28046

**Location 10:**

**City:** Málaga

**Country:** Spain

**Facility:** Hospital Regional de Málaga

**Zip:** 29010

**Location 11:**

**City:** Sevilla

**Country:** Spain

**Facility:** Hospital Virgen Macarena

**Zip:** 41007

#### Overall Officials

**Official 1:**

**Affiliation:** IMONCOLOGY, Hospital la Milagrosa. Madrid

**Name:** Ana Mañas, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Hernanz de Lucas R, Nunez Fernandez M, Gomez-Caamano A, Morera Lopez R, Fortes de la Torre I, de la Torre Tomas A, Munoz-Garzon V, Lopez Bermudo C, Manas Rueda A. Quality of life in patients with breakthrough cancer pain in radiation oncology departments in Spain: the CAVIDIOR study. Future Oncol. 2021 Mar;17(8):943-954. doi: 10.2217/fon-2020-1063. Epub 2020 Dec 8.

**PMID:** 33289432

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M1091

- Name: Cancer Pain

- Relevance: HIGH

- As Found: Cancer Pain

- ID: M29458

- Name: Breakthrough Pain

- Relevance: HIGH

- As Found: Breakthrough Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000072716

- Term: Cancer Pain

- ID: D000059390

- Term: Breakthrough Pain

### Misc Info Module

- Version Holder: 2024-05-24
